ID

14014

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)
  1. 3/22/16 3/22/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 22, 2016

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 PK Sampling TVR

English

VX-950HPC3006 NCT01571583 PK Sampling TVR

1 forms  
PK sampling TVR
Description

PK sampling TVR

actual date and time of most recent intake of telaprevir prior to this visit
Description

most recent intake of telaprevir

Data type

datetime

Alias
UMLS CUI [1,1]
C1876229
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0011008
was most recent Telaprevir dosage taken in fed state?
Description

fed state

Data type

boolean

Alias
UMLS CUI [1,1]
C1876229
UMLS CUI [1,2]
C3174092
actual date and time of sampling
Description

date and time of sampling

Data type

integer

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0011008
remarks, if any
Description

remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

VX-950HPC3006 NCT01571583 PK Sampling TVR

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PK sampling TVR
most recent intake of telaprevir
Item
actual date and time of most recent intake of telaprevir prior to this visit
datetime
C1876229 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
fed state
Item
was most recent Telaprevir dosage taken in fed state?
boolean
C1876229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
actual date and time of sampling
integer
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date and time of sampling
Code List
actual date and time of sampling
CL Item
not done (1)
CL Item
same date as visit date (2)
CL Item
other date please specify (3)
remarks
Item
remarks, if any
text
C0947611 (UMLS CUI [1])
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