ID

14053

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. 3/23/16 3/23/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 23, 2016

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Trial Termination

English

VX-950HPC3006 NCT01571583 Trial Termination

1 forms  
Trial Completion/Discontinuation
Description

Trial Completion/Discontinuation

trial completion/discontinuation
Description

please specify if the subject completed the entire course of the follow-up phase of the trial as specified in the protocol or if the subject discontinued the trial early if discontinued pelase specify the primary reason for early termination in the following items

Data type

integer

Alias
UMLS CUI [1]
C2732579
UMLS CUI [2]
C2718058
adverse event related event, please specify
Description

(including death, abnormal lab values, intercurrent illness and pregnancy)

Data type

text

Alias
UMLS CUI [1]
C0877248
Subject lost to follow-up. Date of last contact with subject (visit, call...) in this trial
Description

Date of last contact with subject

Data type

date

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C0681850
Subject withdrew consent. Date consent withdrawn
Description

date consent withdrawn

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
sponsor's decision
Description

sponsor's decision

Data type

boolean

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0679006
other, please specify
Description

other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
did the subject take all investigational medication within the expiry timeframe?
Description

investigational medication within expiry timeframe

Data type

integer

Alias
UMLS CUI [1]
C0013230
Is the subject rolling over to another Tibotec sponsored Trial?
Description

subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

VX-950HPC3006 NCT01571583 Trial Termination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Trial Completion/Discontinuation
Item
trial completion/discontinuation
integer
C2732579 (UMLS CUI [1])
C2718058 (UMLS CUI [2])
trial completion/discontinuation
Code List
trial completion/discontinuation
CL Item
completed (1)
CL Item
discontinued (2)
adverse event
Item
adverse event related event, please specify
text
C0877248 (UMLS CUI [1])
Date of last contact with subject
Item
Subject lost to follow-up. Date of last contact with subject (visit, call...) in this trial
date
C0805839 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
date consent withdrawn
Item
Subject withdrew consent. Date consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
sponsor's decision
Item
sponsor's decision
boolean
C2347796 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
other reason
Item
other, please specify
text
C3840932 (UMLS CUI [1])
Item
did the subject take all investigational medication within the expiry timeframe?
integer
C0013230 (UMLS CUI [1])
investigational medication within expiry timeframe
Code List
did the subject take all investigational medication within the expiry timeframe?
CL Item
yes (1)
CL Item
no (2)
CL Item
not applicable (3)
subject participation status
Item
Is the subject rolling over to another Tibotec sponsored Trial?
boolean
C2348568 (UMLS CUI [1])
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