ID

13992

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 Graft Donor Pharmacogenomic Informed Consent recording

English

VX-950HPC3006 NCT01571583 Graft Donor Pharmacogenomic Informed Consent recording

1 forms  
Graft Donor Pharmacogenomic Informed Consent recording
Description

Graft Donor Pharmacogenomic Informed Consent recording

Is appropriate consent from graft donor available for Pharmacogenomic sample collection?
Description

If yes, please answer the following two questions If no, please submit form and complete PharGen Graft form

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0021430
date graft donor signed informed consent
Description

date graft donor signed informed consent

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0029206
is a conclusive IL28B test result available?
Description

(either from previous graft donor testing or from a new test result obtained from donor tissue or cells)

Data type

integer

Alias
UMLS CUI [1]
C1174094
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Similar models

VX-950HPC3006 NCT01571583 Graft Donor Pharmacogenomic Informed Consent recording

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Graft Donor Pharmacogenomic Informed Consent recording
appropriate consent from graft donor
Item
Is appropriate consent from graft donor available for Pharmacogenomic sample collection?
boolean
C0013018 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
date graft donor signed informed consent
Item
date graft donor signed informed consent
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0029206 (UMLS CUI [1,3])
Item
is a conclusive IL28B test result available?
integer
C1174094 (UMLS CUI [1])
conclusive IL28B test result
Code List
is a conclusive IL28B test result available?
CL Item
yes, please submit form and complete PharGen Donor form (1)
CL Item
no, please submit form and complete PharGen Graft form (2)
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