ID

14047

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 Study Drug Termination Peg-IFN

English

VX-950HPC3006 NCT01571583 Study Drug Termination Peg-IFN

1 forms  
Study Drug Completion/Discontinuation
Description

Study Drug Completion/Discontinuation

Completed
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

boolean

Alias
UMLS CUI [1]
C0205197
Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

text

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C1279919
UMLS CUI [2]
C0877248
UMLS CUI [3]
C2718058
Discontinued, subject non-compliant
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C1444662
Discontinued, subject ineligible to continue the protocol treatment
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

boolean

Alias
UMLS CUI [1]
C1444662
UMLS CUI [2]
C1512714
Discontinued, subject reached a virologic endpoint
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

boolean

Alias
UMLS CUI [1]
C1444662
UMLS CUI [2,1]
C2349179
UMLS CUI [2,2]
C0205466
Other reason, specify - only applicable for early drug discontinuation without trial termination:
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

text

Alias
UMLS CUI [1]
C3840932
Early trial termination due to reasons other than listed above
Description

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Data type

boolean

Alias
UMLS CUI [1]
C2718058
UMLS CUI [2]
C3840932
Office use only
Description

Office use only

Data type

text

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Similar models

VX-950HPC3006 NCT01571583 Study Drug Termination Peg-IFN

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Drug Completion/Discontinuation
Completed
Item
Completed
boolean
C0205197 (UMLS CUI [1])
Early drug discontinuation
Item
Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
text
C0558681 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C2718058 (UMLS CUI [3])
Discontinued, subject non-compliant
Item
Discontinued, subject non-compliant
boolean
C1321605 (UMLS CUI [1])
C1444662 (UMLS CUI [2])
Discontinued, subject ineligible to continue the protocol treatment
Item
Discontinued, subject ineligible to continue the protocol treatment
boolean
C1444662 (UMLS CUI [1])
C1512714 (UMLS CUI [2])
Discontinued, subject reached a virologic endpoint
Item
Discontinued, subject reached a virologic endpoint
boolean
C1444662 (UMLS CUI [1])
C2349179 (UMLS CUI [2,1])
C0205466 (UMLS CUI [2,2])
Other reason
Item
Other reason, specify - only applicable for early drug discontinuation without trial termination:
text
C3840932 (UMLS CUI [1])
Early trial termination
Item
Early trial termination due to reasons other than listed above
boolean
C2718058 (UMLS CUI [1])
C3840932 (UMLS CUI [2])
Office use only
Item
Office use only
text
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