ID

13993

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 sample collection

English

VX-950HPC3006 NCT01571583 Graft Donor Pharmacogenomic sample collection

1 forms  
Graft Donor Pharmacogenomic sample collection
Description

Graft Donor Pharmacogenomic sample collection

Is a conclusive donor IL28B test result available from previous graft donor testing?
Description

if yes, please provide details if no, please provide details of new conclusive IL28B test result obtained from donor tissue or cells

Data type

boolean

Alias
UMLS CUI [1]
C1174094
Conclusive IL28B test result available
Description

Conclusive IL28B test result available

Alias
UMLS CUI-1
C1174094
actual date of collection
Description

actual date of collection

Data type

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
IL28B rs12979860 genotype
Description

IL28B rs12979860 genotype

Data type

integer

Alias
UMLS CUI [1]
C3476056
type of sample
Description

type of sample

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0040300
No conclusive donor IL28B test result available
Description

No conclusive donor IL28B test result available

actual date of collection
Description

actual date of collection

Data type

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
central laboratoy reference number
Description

central laboratoy reference number

Data type

text

Alias
UMLS CUI [1,1]
C2826265
UMLS CUI [1,2]
C1880016
type of sample
Description

type of sample

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0040300
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Similar models

VX-950HPC3006 NCT01571583 Graft Donor Pharmacogenomic sample collection

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Graft Donor Pharmacogenomic sample collection
conclusive donor IL28B test result
Item
Is a conclusive donor IL28B test result available from previous graft donor testing?
boolean
C1174094 (UMLS CUI [1])
Item Group
Conclusive IL28B test result available
C1174094 (UMLS CUI-1)
actual date of collection
Item
actual date of collection
date
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
IL28B rs12979860 genotype
integer
C3476056 (UMLS CUI [1])
IL28B rs12979860 genotype
Code List
IL28B rs12979860 genotype
CL Item
CC (1)
CL Item
CT (2)
CL Item
TT (3)
Item
type of sample
integer
C0332307 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
sample type
Code List
type of sample
CL Item
whole blood (preferred) (1)
CL Item
liver tissue biopsy (2)
CL Item
lymph node tissue biopsy (3)
CL Item
other, please specify: (4)
Item Group
No conclusive donor IL28B test result available
actual date of collection
Item
actual date of collection
date
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
central laboratoy reference number
Item
central laboratoy reference number
text
C2826265 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
Item
type of sample
integer
C0332307 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
type of sample
Code List
type of sample
CL Item
whole blood (preferred) (1)
CL Item
liver tissue biopsy (2)
CL Item
lymph node tissue biopsy (3)
CL Item
other, please specify: (4)
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