ID

44660

Description

ODM derived from http://clinicaltrials.gov/show/NCT01174446

Link

http://clinicaltrials.gov/show/NCT01174446

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01174446 Hemophilia B

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 12 Years to 65 Years
Description

age 12 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subject is 12 to 65 years old at the time of screening
Description

Subject is 12 to 65 years old at the time of screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1409616
Subject and/or legal representative has/have provided signed informed consent
Description

Subject and/or legal representative has/have provided signed informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
Description

Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0008533
SNOMED CT 2011_0131
41788008
MedDRA 14.1
10016077
ICD-10-CM Version 2010
D67
ICD-9-CM Version 2011
286.1
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0200408
SNOMED CT 2011_0131
78882004
MedDRA 14.1
10009744
UMLS CUI 2011AA
C1705938
UMLS CUI 2011AA
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)
Description

Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C2964352
LOINC Version 232
MTHU036409
UMLS CUI 2011AA
C1514798
UMLS CUI 2011AA
C0360726
SNOMED CT 2011_0131
346428009
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
Description

Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
Description

The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
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
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
Description

The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory

Data type

boolean

Alias
UMLS CUI 2011AA
C1511790
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0475208
SNOMED CT 2011_0131
118590008
UMLS CUI 2011AA
C0439151
SNOMED CT 2011_0131
258725007
HL7 V3 2006_05
[BETH'U]
Abnormal weight (finding)
Description

The subject's weight is < 35 kg or > 120 kg

Data type

boolean

Alias
UMLS CUI 2011AA
C0578026
SNOMED CT 2011_0131
22495007
MedDRA 14.1
10056814
The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
Description

The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0360726
SNOMED CT 2011_0131
346428009
The subject has a known hypersensitivity to hamster proteins or rFurin
Description

The subject has a known hypersensitivity to hamster proteins or rFurin

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0018557
SNOMED CT 2011_0131
392390005
UMLS CUI 2011AA
C0033684
SNOMED CT 2011_0131
88878007
LOINC Version 232
MTHU001951
UMLS CUI 2011AA
C1514798
UMLS CUI 2011AA
C0287990
SNOMED CT 2011_0131
130632003
The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC
Description

The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0040053
SNOMED CT 2011_0131
439127006
MedDRA 14.1
10043607
UMLS CUI 2011AA
C0016017
SNOMED CT 2011_0131
385538006
UMLS CUI 2011AA
C0012739
SNOMED CT 2011_0131
67406007
MedDRA 14.1
10013442
ICD-10-CM Version 2010
D65
ICD-9-CM Version 2011
286.6
CTCAE 1105E
E10028
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 12 Years to 65 Years
Item
age 12 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject is 12 to 65 years old at the time of screening
Item
Subject is 12 to 65 years old at the time of screening
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Subject and/or legal representative has/have provided signed informed consent
Item
Subject and/or legal representative has/have provided signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
Item
Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level <= 2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0008533 (UMLS CUI 2011AA)
41788008 (SNOMED CT 2011_0131)
10016077 (MedDRA 14.1)
D67 (ICD-10-CM Version 2010)
286.1 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0200408 (UMLS CUI 2011AA)
78882004 (SNOMED CT 2011_0131)
10009744 (MedDRA 14.1)
C1705938 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)
Item
Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records)
boolean
C1514463 (UMLS CUI 2011AA)
C2964352 (UMLS CUI 2011AA)
MTHU036409 (LOINC Version 232)
C1514798 (UMLS CUI 2011AA)
C0360726 (UMLS CUI 2011AA)
346428009 (SNOMED CT 2011_0131)
C1524031 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
Item
Subject has no evidence of a history of FIX inhibitors (based on the subject's medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
Item
The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
Item
The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
boolean
C1511790 (UMLS CUI 2011AA)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0475208 (UMLS CUI 2011AA)
118590008 (SNOMED CT 2011_0131)
C0439151 (UMLS CUI 2011AA)
258725007 (SNOMED CT 2011_0131)
[BETH'U] (HL7 V3 2006_05)
The subject's weight is < 35 kg or > 120 kg
Item
Abnormal weight (finding)
boolean
C0578026 (UMLS CUI 2011AA)
22495007 (SNOMED CT 2011_0131)
10056814 (MedDRA 14.1)
The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
Item
The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0360726 (UMLS CUI 2011AA)
346428009 (SNOMED CT 2011_0131)
The subject has a known hypersensitivity to hamster proteins or rFurin
Item
The subject has a known hypersensitivity to hamster proteins or rFurin
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0018557 (UMLS CUI 2011AA)
392390005 (SNOMED CT 2011_0131)
C0033684 (UMLS CUI 2011AA)
88878007 (SNOMED CT 2011_0131)
MTHU001951 (LOINC Version 232)
C1514798 (UMLS CUI 2011AA)
C0287990 (UMLS CUI 2011AA)
130632003 (SNOMED CT 2011_0131)
The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC
Item
The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0040053 (UMLS CUI 2011AA)
439127006 (SNOMED CT 2011_0131)
10043607 (MedDRA 14.1)
C0016017 (UMLS CUI 2011AA)
385538006 (SNOMED CT 2011_0131)
C0012739 (UMLS CUI 2011AA)
67406007 (SNOMED CT 2011_0131)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)
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