ID

43465

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00816660

Länk

http://clinicaltrials.gov/show/NCT00816660

Nyckelord

Versioner (3)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-04-16 2014-04-16 - Julian Varghese
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00816660 Von Willebrand Disease

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 60 Jahre
Beskrivning

age 18 Years to 60 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subject has voluntarily given written informed consent (before conduct of any study-related procedures)
Beskrivning

Subject has voluntarily given written informed consent (before conduct of any study-related procedures)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)
Beskrivning

The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1264041
SNOMED CT 2011_0131
128108002
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1264039
SNOMED CT 2011_0131
128106003
UMLS CUI 2011AA
C1282968
SNOMED CT 2011_0131
359714009
The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates
Beskrivning

The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0042971
SNOMED CT 2011_0131
18288009
LOINC Version 232
MTHU024978
UMLS CUI 2011AA
C0005789
SNOMED CT 2011_0131
350475008
UMLS CUI 2011AA
C2003864
Karnofsky performance status (assessment scale)
Beskrivning

The subject has a Karnofsky score >= 70%

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit
Beskrivning

NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0022277
SNOMED CT 2011_0131
223668000
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion
Beskrivning

APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0022277
SNOMED CT 2011_0131
223668000
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0458083
SNOMED CT 2011_0131
278994005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Beskrivning

NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0022277
SNOMED CT 2011_0131
223668000
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0005789
SNOMED CT 2011_0131
350475008
UMLS CUI 2011AA
C0031328
UMLS CUI 2011AA
C1879533
UMLS CUI 2011AA
CL424941
APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Beskrivning

APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0022277
SNOMED CT 2011_0131
223668000
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0005789
SNOMED CT 2011_0131
350475008
UMLS CUI 2011AA
C0031328
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)
Beskrivning

The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0042974
SNOMED CT 2011_0131
128105004
MedDRA 14.1
10047715
ICD-10-CM Version 2010
D68.0
ICD-9-CM Version 2011
286.4
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0005818
SNOMED CT 2011_0131
22716005
MedDRA 14.1
10035532
UMLS CUI 2011AA
CL415281
The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity
Beskrivning

The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0389918
LOINC Version 232
MTHU025106
UMLS CUI 2011AA
CL426295
UMLS CUI 2011AA
C0441655
SNOMED CT 2011_0131
257733005
LOINC Version 232
MTHU002837
ICD-9-CM Version 2011
E001-E030.9
von-Willebrand-Faktor-Inhibitor
Beskrivning

The subject has a history or presence of VWF inhibitor

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0313543
SNOMED CT 2011_0131
1914001
The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
Beskrivning

The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0368953
SNOMED CT 2011_0131
58730008
LOINC Version 232
MTHU014157
UMLS CUI 2011AA
C0475208
SNOMED CT 2011_0131
118590008
UMLS CUI 2011AA
C0439151
SNOMED CT 2011_0131
258725007
HL7 V3 2006_05
[BETH'U]
UMLS CUI 2011AA
C1510438
SNOMED CT 2011_0131
272392009
The subject has a known hypersensitivity to mouse or hamster proteins
Beskrivning

The subject has a known hypersensitivity to mouse or hamster proteins

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1334805
UMLS CUI 2011AA
C0018557
SNOMED CT 2011_0131
392390005
UMLS CUI 2011AA
C0033684
SNOMED CT 2011_0131
88878007
LOINC Version 232
MTHU001951
The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies
Beskrivning

The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0021053
SNOMED CT 2011_0131
71922006
MedDRA 14.1
10021425
ICD-10-CM Version 2010
D89.9
ICD-9-CM Version 2011
279.9
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0348688
ICD-10-CM Version 2010
J30.2
UMLS CUI 2011AA
C0339164
SNOMED CT 2011_0131
231855007
UMLS CUI 2011AA
C0016470
SNOMED CT 2011_0131
414285001
MedDRA 14.1
10016946
HL7 V3 2006_05
FALG
UMLS CUI 2011AA
C0003062
SNOMED CT 2011_0131
387961004
HL7 V3 2006_05
ANM
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
The subject has a medical history of a thromboembolic event
Beskrivning

The subject has a medical history of a thromboembolic event

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0040038
MedDRA 14.1
10043565
The subject is HIV positive with an absolute CD4 count < 200/mm3
Beskrivning

The subject is HIV positive with an absolute CD4 count < 200/mm3

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C1277776
SNOMED CT 2011_0131
313660005
The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)
Beskrivning

The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C1319793
SNOMED CT 2011_0131
420300004
MedDRA 14.1
10064079
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
The subject has been diagnosed with insulin-dependent diabetes mellitus
Beskrivning

The subject has been diagnosed with insulin-dependent diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)
Beskrivning

The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001314
SNOMED CT 2011_0131
2704003
UMLS CUI 2011AA
C0021400
SNOMED CT 2011_0131
6142004
MedDRA 14.1
10022000
ICD-10-CM Version 2010
J11.1
ICD-9-CM Version 2011
487
UMLS CUI 2011AA
C1558931
CTCAE 1105E
MTHU116939
UMLS CUI 2011AA
C2607914
SNOMED CT 2011_0131
61582004
MedDRA 14.1
10039085
ICD-10-CM Version 2010
J30.9
ICD-9-CM Version 2011
477.9
CTCAE 1105E
E13303
UMLS CUI 2011AA
C0009766
SNOMED CT 2011_0131
231854006
MedDRA 14.1
10010744
The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)
Beskrivning

The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0239981
SNOMED CT 2011_0131
119247004
MedDRA 14.1
10020942
CTCAE 1105E
E12310
UMLS CUI 2011AA
C0020541
SNOMED CT 2011_0131
34742003
MedDRA 14.1
10036200
ICD-10-CM Version 2010
K76.6
ICD-9-CM Version 2011
572.3
CTCAE 1105E
E11238
UMLS CUI 2011AA
C0038002
SNOMED CT 2011_0131
16294009
MedDRA 14.1
10041660
ICD-10-CM Version 2010
R16.1
ICD-9-CM Version 2011
789.2
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014867
SNOMED CT 2011_0131
28670008
MedDRA 14.1
10030209
ICD-10-CM Version 2010
I85
The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL
Beskrivning

The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject
Beskrivning

In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0243087
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
Beskrivning

The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0028912
SNOMED CT 2011_0131
417519007
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C0461725
SNOMED CT 2011_0131
385157007
HL7 V3 2006_05
NASSPRY
The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment
Beskrivning

The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0034155
SNOMED CT 2011_0131
78129009
MedDRA 14.1
10043648
ICD-10-CM Version 2010
M31.1
CTCAE 1105E
E10061
UMLS CUI 2011AA
C1373149
UMLS CUI 2011AA
C0070166
SNOMED CT 2011_0131
386952008
UMLS CUI 2011AA
C0040207
SNOMED CT 2011_0131
108971003
LOINC Version 232
MTHU001495
The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment
Beskrivning

The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0013227
The subject is a lactating female
Beskrivning

The subject is a lactating female

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
The subject has a history of drug or alcohol abuse within the last 5 years
Beskrivning

The subject has a history of drug or alcohol abuse within the last 5 years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0085762
The subject has a progressive fatal disease and/or life expectancy of < 3 months
Beskrivning

The subject has a progressive fatal disease and/or life expectancy of < 3 months

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1302234
SNOMED CT 2011_0131
399166001
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
Beskrivning

The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C0680734
The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
Beskrivning

The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0809986
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0424350
SNOMED CT 2011_0131
248042003
Subject is in prison or compulsory detention by regulatory and/or juridical order
Beskrivning

Subject is in prison or compulsory detention by regulatory and/or juridical order

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0392751
SNOMED CT 2011_0131
91497007
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 60 Years
Item
Alter 18 bis 60 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject has voluntarily given written informed consent (before conduct of any study-related procedures)
Item
Subject has voluntarily given written informed consent (before conduct of any study-related procedures)
boolean
C0021430 (UMLS CUI 2011AA)
The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)
Item
The subject has hereditary type 3 VWD (<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo <= 10% and FVIII:C <20%)
boolean
C1264041 (UMLS CUI 2011AA)
128108002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1264039 (UMLS CUI 2011AA)
128106003 (SNOMED CT 2011_0131)
C1282968 (UMLS CUI 2011AA)
359714009 (SNOMED CT 2011_0131)
The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates
Item
The subject has a medical history of at least 25 exposure days to VWF/FVIII coagulation factor concentrates
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0042971 (UMLS CUI 2011AA)
18288009 (SNOMED CT 2011_0131)
MTHU024978 (LOINC Version 232)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C2003864 (UMLS CUI 2011AA)
The subject has a Karnofsky score >= 70%
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit
Item
NOT APPLICABLE IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice contraception using a method of proven reliability from the day of screening until the study completion visit
boolean
C1518422 (UMLS CUI 2011AA)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion
Item
APPLICABLE ONLY IN ITALY: Female subjects of child-bearing potential must have a negative pregnancy test and agree to practice non-hormonal-based contraception using a method of proven reliability (IUD acceptable) from the day of screening until 96 hours after the last investigational drug infusion
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Item
NOT APPLICABLE IN ITALY: The subject must agree not to be on any therapy (hormone-based contraception acceptable) interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
boolean
C1518422 (UMLS CUI 2011AA)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C0031328 (UMLS CUI 2011AA)
C1879533 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
Item
APPLICABLE ONLY IN ITALY: The subject must agree not to be on any therapy interfering with coagulation factor pharmacokinetics until 96 hours after the last investigational drug infusion
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0022277 (UMLS CUI 2011AA)
223668000 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0005789 (UMLS CUI 2011AA)
350475008 (SNOMED CT 2011_0131)
C0031328 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)
Item
The subject has been diagnosed with a hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders and/or an international normalized ratio (INR) > 1.4)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0042974 (UMLS CUI 2011AA)
128105004 (SNOMED CT 2011_0131)
10047715 (MedDRA 14.1)
D68.0 (ICD-10-CM Version 2010)
286.4 (ICD-9-CM Version 2011)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0005818 (UMLS CUI 2011AA)
22716005 (SNOMED CT 2011_0131)
10035532 (MedDRA 14.1)
CL415281 (UMLS CUI 2011AA)
The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity
Item
The subject has been diagnosed with an ADAMTS13 deficiency with < 10% ADAMTS13 activity
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0389918 (UMLS CUI 2011AA)
MTHU025106 (LOINC Version 232)
CL426295 (UMLS CUI 2011AA)
C0441655 (UMLS CUI 2011AA)
257733005 (SNOMED CT 2011_0131)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
The subject has a history or presence of VWF inhibitor
Item
von-Willebrand-Faktor-Inhibitor
boolean
C0313543 (UMLS CUI 2011AA)
1914001 (SNOMED CT 2011_0131)
The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
Item
The subject has a history or presence of FVIII inhibitor with a titer >= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)
boolean
C0368953 (UMLS CUI 2011AA)
58730008 (SNOMED CT 2011_0131)
MTHU014157 (LOINC Version 232)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
The subject has a known hypersensitivity to mouse or hamster proteins
Item
The subject has a known hypersensitivity to mouse or hamster proteins
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1334805 (UMLS CUI 2011AA)
C0018557 (UMLS CUI 2011AA)
392390005 (SNOMED CT 2011_0131)
C0033684 (UMLS CUI 2011AA)
88878007 (SNOMED CT 2011_0131)
MTHU001951 (LOINC Version 232)
The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies
Item
The subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, food allergies or animal allergies
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021053 (UMLS CUI 2011AA)
71922006 (SNOMED CT 2011_0131)
10021425 (MedDRA 14.1)
D89.9 (ICD-10-CM Version 2010)
279.9 (ICD-9-CM Version 2011)
CL411789 (UMLS CUI 2011AA)
C0348688 (UMLS CUI 2011AA)
J30.2 (ICD-10-CM Version 2010)
C0339164 (UMLS CUI 2011AA)
231855007 (SNOMED CT 2011_0131)
C0016470 (UMLS CUI 2011AA)
414285001 (SNOMED CT 2011_0131)
10016946 (MedDRA 14.1)
FALG (HL7 V3 2006_05)
C0003062 (UMLS CUI 2011AA)
387961004 (SNOMED CT 2011_0131)
ANM (HL7 V3 2006_05)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
The subject has a medical history of a thromboembolic event
Item
The subject has a medical history of a thromboembolic event
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0040038 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
The subject is HIV positive with an absolute CD4 count < 200/mm3
Item
The subject is HIV positive with an absolute CD4 count < 200/mm3
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C1277776 (UMLS CUI 2011AA)
313660005 (SNOMED CT 2011_0131)
The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)
Item
The subject has been diagnosed with cardiovascular disease (New York Heart Association (NYHA) classes 1-4)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
The subject has been diagnosed with insulin-dependent diabetes mellitus
Item
The subject has been diagnosed with insulin-dependent diabetes mellitus
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)
Item
The subject has an acute illness (e.g. influenza, flu-like syndrome, allergic rhinitis/conjunctivitis)
boolean
C0001314 (UMLS CUI 2011AA)
2704003 (SNOMED CT 2011_0131)
C0021400 (UMLS CUI 2011AA)
6142004 (SNOMED CT 2011_0131)
10022000 (MedDRA 14.1)
J11.1 (ICD-10-CM Version 2010)
487 (ICD-9-CM Version 2011)
C1558931 (UMLS CUI 2011AA)
MTHU116939 (CTCAE 1105E)
C2607914 (UMLS CUI 2011AA)
61582004 (SNOMED CT 2011_0131)
10039085 (MedDRA 14.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE 1105E)
C0009766 (UMLS CUI 2011AA)
231854006 (SNOMED CT 2011_0131)
10010744 (MedDRA 14.1)
The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)
Item
The subject has been diagnosed with liver disease, as evidenced by, but not limited to, any of the following: serum ALT three times the upper limit of normal, hypoalbuminemia, portal vein hypertension (e.g. presence of otherwise unexplained splenomegaly, history of esophageal varices)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0239981 (UMLS CUI 2011AA)
119247004 (SNOMED CT 2011_0131)
10020942 (MedDRA 14.1)
E12310 (CTCAE 1105E)
C0020541 (UMLS CUI 2011AA)
34742003 (SNOMED CT 2011_0131)
10036200 (MedDRA 14.1)
K76.6 (ICD-10-CM Version 2010)
572.3 (ICD-9-CM Version 2011)
E11238 (CTCAE 1105E)
C0038002 (UMLS CUI 2011AA)
16294009 (SNOMED CT 2011_0131)
10041660 (MedDRA 14.1)
R16.1 (ICD-10-CM Version 2010)
789.2 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014867 (UMLS CUI 2011AA)
28670008 (SNOMED CT 2011_0131)
10030209 (MedDRA 14.1)
I85 (ICD-10-CM Version 2010)
The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL
Item
The subject has been diagnosed with renal disease, with a serum creatinine level >= 2 mg/dL
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject
Item
In the judgment of the investigator, the subject has another clinically significant concomitant disease (e.g. uncontrolled hypertension, diabetes type II) that may pose additional risks for the subject
boolean
C0243087 (UMLS CUI 2011AA)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
Item
The subject has been treated with an immunomodulatory drug, excluding topical treatment (e.g. ointments, nasal sprays) within 30 days before enrollment
boolean
CL415147 (UMLS CUI 2011AA)
C0005525 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0028912 (UMLS CUI 2011AA)
417519007 (SNOMED CT 2011_0131)
OINT (HL7 V3 2006_05)
C0461725 (UMLS CUI 2011AA)
385157007 (SNOMED CT 2011_0131)
NASSPRY (HL7 V3 2006_05)
The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment
Item
The subject has been treated with drugs known to induce thrombotic thrombocytopenic purpura (TTP) (e.g. Adenosine diphosphate (ADP) receptor inhibitors (Clopidogrel, Ticlopidine)) within 60 days before enrollment
boolean
CL415147 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0034155 (UMLS CUI 2011AA)
78129009 (SNOMED CT 2011_0131)
10043648 (MedDRA 14.1)
M31.1 (ICD-10-CM Version 2010)
E10061 (CTCAE 1105E)
C1373149 (UMLS CUI 2011AA)
C0070166 (UMLS CUI 2011AA)
386952008 (SNOMED CT 2011_0131)
C0040207 (UMLS CUI 2011AA)
108971003 (SNOMED CT 2011_0131)
MTHU001495 (LOINC Version 232)
The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment
Item
The subject is receiving or anticipates receiving another investigational and/or interventional drug within 30 days before enrollment
boolean
C1514756 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0013227 (UMLS CUI 2011AA)
The subject is a lactating female
Item
The subject is a lactating female
boolean
C2828358 (UMLS CUI 2011AA)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
The subject has a history of drug or alcohol abuse within the last 5 years
Item
The subject has a history of drug or alcohol abuse within the last 5 years
boolean
C0085762 (UMLS CUI 2011AA)
The subject has a progressive fatal disease and/or life expectancy of < 3 months
Item
The subject has a progressive fatal disease and/or life expectancy of < 3 months
boolean
C1302234 (UMLS CUI 2011AA)
399166001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
Item
The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
C0680734 (UMLS CUI 2011AA)
The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
Item
The subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
boolean
C0809986 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0424350 (UMLS CUI 2011AA)
248042003 (SNOMED CT 2011_0131)
Subject is in prison or compulsory detention by regulatory and/or juridical order
Item
Subject is in prison or compulsory detention by regulatory and/or juridical order
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0392751 (UMLS CUI 2011AA)
91497007 (SNOMED CT 2011_0131)
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