ID
13983
Description
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583
Keywords
Versions (1)
- 3/21/16 3/21/16 -
Copyright Holder
CC BY-NC 3.0
Uploaded on
March 21, 2016
DOI
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License
Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Eligibility
VX-950HPC3006 NCT01571583 Eligibility
- StudyEvent: ODM
Description
Reason for withdrawal from study
Description
inclusion/exclusion criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
Description
(including death, abnormal lab values, intercurrent illness and pregnancy)
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Date of last contact with subject
Data type
date
Alias
- UMLS CUI [1,1]
- C0805839
- UMLS CUI [1,2]
- C0681850
Description
date consent withdrawn
Data type
date
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C0011008
Description
subject non-compliant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457432
- UMLS CUI [1,2]
- C0681850
Description
sponsor's decision
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C0679006
Description
other reason
Data type
text
Alias
- UMLS CUI [1]
- C3840932
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VX-950HPC3006 NCT01571583 Eligibility
- StudyEvent: ODM
C2348563 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2])
C0680095 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])