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)
  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

English

VX-950HPC3006 NCT01571583 Eligibility

1 forms  
Eligibility
Description

Eligibility

Does the subject meet all eligibility criteria for the trial?
Description

eligibility criteria

Data type

boolean

Alias
UMLS CUI [1]
C0013893
If nom please list the number of inclusion criteria not met (if applicable)
Description

inclusion criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
If no, please list the number of exclusion criteria not met (if applicable)
Description

exclusion criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Please provide the date of protocol in effect at the time of screening
Description

date of protocol at time of screening

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0220908
Is the subject a screening failure?
Description

If yes, please complete the question below (reason for withdrawal)

Data type

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0680095
Reason for withdrawal from study
Description

Reason for withdrawal from study

Subject did not fullfill all inclusion/exlusion criteria
Description

inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
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
subject non-compliant
Description

subject non-compliant

Data type

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0681850
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
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Similar models

VX-950HPC3006 NCT01571583 Eligibility

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility
eligibility criteria
Item
Does the subject meet all eligibility criteria for the trial?
boolean
C0013893 (UMLS CUI [1])
inclusion criteria
Item
If nom please list the number of inclusion criteria not met (if applicable)
text
C1512693 (UMLS CUI [1])
exclusion criteria
Item
If no, please list the number of exclusion criteria not met (if applicable)
text
C0680251 (UMLS CUI [1])
date of protocol at time of screening
Item
Please provide the date of protocol in effect at the time of screening
date
C0011008 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2])
screening failure
Item
Is the subject a screening failure?
boolean
C1710477 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
Item Group
Reason for withdrawal from study
inclusion/exclusion criteria
Item
Subject did not fullfill all inclusion/exlusion criteria
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [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])
subject non-compliant
Item
subject non-compliant
boolean
C0457432 (UMLS CUI [1,1])
C0681850 (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])
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