ID

43286

Description

ODM derived from http://clinicaltrials.gov/show/NCT01286779

Link

http://clinicaltrials.gov/show/NCT01286779

Keywords

Versions (2)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01286779 Hemophilia B

German English

Eligibility

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

Inclusion Criteria

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 and/or legal representative has/have voluntarily provided signed informed consent
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C0030701
UMLS CUI 2011AA
C1709695
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0021430
Subject has completed Baxter clinical study 250901
Description

Subject has completed Baxter clinical study 250901

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1552884
HL7 V3 2006_05
BA
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Subject has severe (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 (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
C0200408
SNOMED CT 2011_0131
78882004
MedDRA 14.1
10009744
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
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
Subject has not developed an inhibitory FIX antibody during Baxter clinical study 250901
Description

Subject has not developed an inhibitory FIX antibody during Baxter clinical study 250901

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1511795
UMLS CUI 2011AA
C0302077
SNOMED CT 2011_0131
36020009
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1552884
HL7 V3 2006_05
BA
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Exclusion Criteria
Description

Exclusion Criteria

Subject received factor IX product(s) other than BAX 326 upon completion of Baxter protocol 250901
Description

Subject received factor IX product(s) other than BAX 326 upon completion of Baxter protocol 250901

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0015491
SNOMED CT 2011_0131
424562004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1552884
HL7 V3 2006_05
BA
UMLS CUI 2011AA
C1514468
Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
Description

Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439661
SNOMED CT 2011_0131
255396000
UMLS CUI 2011AA
C0019116
SNOMED CT 2011_0131
74848003
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
UMLS CUI 2011AA
CL411789
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
Body weight (observable entity)
Description

Subject's weight is < 35 kg or > 120 kg

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the continuation study
Description

Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the continuation study

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1552884
HL7 V3 2006_05
BA
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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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
age 12 Years to 65 Years
Item
age 12 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject and/or legal representative has/have voluntarily provided signed informed consent
Item
Subject and/or legal representative has/have voluntarily provided signed informed consent
boolean
C0681850 (UMLS CUI 2011AA)
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C0030701 (UMLS CUI 2011AA)
C1709695 (UMLS CUI 2011AA)
C1519316 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
Subject has completed Baxter clinical study 250901
Item
Subject has completed Baxter clinical study 250901
boolean
C0681850 (UMLS CUI 2011AA)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1552884 (UMLS CUI 2011AA)
BA (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Subject has severe (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 (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
C0200408 (UMLS CUI 2011AA)
78882004 (SNOMED CT 2011_0131)
10009744 (MedDRA 14.1)
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)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
Subject has not developed an inhibitory FIX antibody during Baxter clinical study 250901
Item
Subject has not developed an inhibitory FIX antibody during Baxter clinical study 250901
boolean
C1518422 (UMLS CUI 2011AA)
C1511795 (UMLS CUI 2011AA)
C0302077 (UMLS CUI 2011AA)
36020009 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1552884 (UMLS CUI 2011AA)
BA (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Subject received factor IX product(s) other than BAX 326 upon completion of Baxter protocol 250901
Item
Subject received factor IX product(s) other than BAX 326 upon completion of Baxter protocol 250901
boolean
C1514756 (UMLS CUI 2011AA)
C0015491 (UMLS CUI 2011AA)
424562004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1552884 (UMLS CUI 2011AA)
BA (HL7 V3 2006_05)
C1514468 (UMLS CUI 2011AA)
Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
Item
Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0019116 (UMLS CUI 2011AA)
74848003 (SNOMED CT 2011_0131)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
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)
Subject's weight is < 35 kg or > 120 kg
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the continuation study
Item
Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the continuation study
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1552884 (UMLS CUI 2011AA)
BA (HL7 V3 2006_05)
C0038895 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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