ID
3675
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT01233440
Link
http://clinicaltrials.gov/show/NCT01233440
Palavras-chave
Versões (3)
- 12/02/2013 12/02/2013 - Martin Dugas
- 19/04/2014 19/04/2014 - Julian Varghese
- 27/09/2021 27/09/2021 -
Transferido a
12 de fevereiro de 2013
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01233440 Hemophilia B
Eligibility
- StudyEvent: Eligibility
Descrição
Ausschlusskriterien
Descrição
Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- 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
- C1827657
- SNOMED CT 2011_0131
- 424562004
- UMLS CUI 2011AA
- C0018557
- SNOMED CT 2011_0131
- 392390005
- UMLS CUI 2011AA
- C0033684
- SNOMED CT 2011_0131
- 88878007
- LOINC Version 232
- MTHU001951
Descrição
Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0005779
- SNOMED CT 2011_0131
- 64779008
- MedDRA 14.1
- 10009802
- ICD-10-CM Version 2010
- D68.9
- UMLS CUI 2011AA
- C0398622
- SNOMED CT 2011_0131
- 234466008
- 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
Descrição
Platelet count < 100,000/microL
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- LOINC Version 232
- 777-3
Descrição
Immunocompromised (CD4 count < 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0085393
- SNOMED CT 2011_0131
- 370388006
- UMLS CUI 2011AA
- C1277776
- SNOMED CT 2011_0131
- 313660005
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
- UMLS CUI 2011AA
- C0521104
- SNOMED CT 2011_0131
- 75554001
- UMLS CUI 2011AA
- C0033607
- SNOMED CT 2011_0131
- 412127001
- UMLS CUI 2011AA
- C2363964
- MedDRA 14.1
- 10068724
Descrição
Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0005525
- UMLS CUI 2011AA
- C0021027
- SNOMED CT 2011_0131
- 399771004
- HL7 V3 2006_05
- 14
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C1515119
Descrição
Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 times (x) the upper limit of normal (ULN)
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
Descrição
Serum creatinine > 2 x ULN
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1519815
Descrição
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0040053
- SNOMED CT 2011_0131
- 439127006
- MedDRA 14.1
- 10043607
- UMLS CUI 2011AA
- C0149871
- SNOMED CT 2011_0131
- 128053003
- MedDRA 14.1
- 10051055
- ICD-10-CM Version 2010
- I82.40
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0034065
- SNOMED CT 2011_0131
- 59282003
- MedDRA 14.1
- 10037377
- ICD-10-CM Version 2010
- I26
- ICD-9-CM Version 2011
- 415.1
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0549124
- SNOMED CT 2011_0131
- 54687002
- MedDRA 14.1
- 10014513
Descrição
Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C1514468
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1514798
- UMLS CUI 2011AA
- C0015491
- SNOMED CT 2011_0131
- 54378000
- UMLS CUI 2011AA
- C0162768
- SNOMED CT 2011_0131
- 422055000
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
Descrição
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C2826244
- UMLS CUI 2011AA
- C1970394
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C0162439
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Descrição
Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- CL031856
- UMLS CUI 2011AA
- C0015491
- SNOMED CT 2011_0131
- 54378000
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0019080
- SNOMED CT 2011_0131
- 50960005
- MedDRA 14.1
- 10055798
- ICD-10-CM Version 2010
- R58
- ICD-9-CM Version 2011
- 459.0
Descrição
Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0023015
- SNOMED CT 2011_0131
- 62305002
- ICD-10-CM Version 2010
- F80.9
- UMLS CUI 2011AA
- C0278060
- SNOMED CT 2011_0131
- 36456004
- LOINC Version 232
- MTHU001424
- CTCAE 1105E
- MTHU117157
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C0496735
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Eligibility
- StudyEvent: Eligibility
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56935002 (SNOMED CT 2011_0131)
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10040230 (MedDRA 14.1)
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439127006 (SNOMED CT 2011_0131)
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422055000 (SNOMED CT 2011_0131)
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