ID

14007

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

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 First Intakes Of Study Medication

English

VX-950HPC3006 NCT01571583 First Intakes Of Study Medication

1 forms  
First Intakes Of Study Medication
Description

First Intakes Of Study Medication

actual date and time of first intake of telaprevir during this trial
Description

first intake of telaprevir

Data type

datetime

Alias
UMLS CUI [1,1]
C1876229
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0011008
actual date of first intake of ribavirin during this trial
Description

date of first intake of ribavirin

Data type

datetime

Alias
UMLS CUI [1,1]
C0035525
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0011008
actual date and time of first administration of PEG-IFN during this trial
Description

date and time of first administration of PEG-IFN

Data type

datetime

Alias
UMLS CUI [1,1]
C0907160
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0011008
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Similar models

VX-950HPC3006 NCT01571583 First Intakes Of Study Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
First Intakes Of Study Medication
first intake of telaprevir
Item
actual date and time of first intake of telaprevir during this trial
datetime
C1876229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
date of first intake of ribavirin
Item
actual date of first intake of ribavirin during this trial
datetime
C0035525 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
date and time of first administration of PEG-IFN
Item
actual date and time of first administration of PEG-IFN during this trial
datetime
C0907160 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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