ID

14120

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. 3/30/16 3/30/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 30, 2016

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Biopsy [FRMBIOPSYUNS]

English

VX-950HPC3006 NCT01571583 BiopsyVX-950HPC3006 NCT01571583 Biopsy [FRMBIOPSYUNS]

1 forms  
Liver Graft Biopsy Result
Description

Liver Graft Biopsy Result

Date of biopsy
Description

Date of biopsy

Data type

integer

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
if other date please specify
Description

other date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205394
liver fibrosis score (metavir)
Description

liver fibrosis score (metavir)

Data type

integer

Alias
UMLS CUI [1]
C3897040
Inflammation score (metavir)
Description

Inflammation score (metavir)

Data type

integer

Alias
UMLS CUI [1]
C3888527
Is there steatosis?
Description

If yes, please specify in the following item

Data type

boolean

Alias
UMLS CUI [1]
C2711227
Hepatic steatosis grade
Description

Hepatic steatosis grade

Data type

integer

Alias
UMLS CUI [1]
C2711227
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Similar models

VX-950HPC3006 NCT01571583 BiopsyVX-950HPC3006 NCT01571583 Biopsy [FRMBIOPSYUNS]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Liver Graft Biopsy Result
Item
Date of biopsy
integer
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of biopsy
Code List
Date of biopsy
CL Item
same date as visit date (1)
CL Item
other date, please specify (2)
other date
Item
if other date please specify
date
C0011008 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
liver fibrosis score (metavir)
integer
C3897040 (UMLS CUI [1])
liver fibrosis score
Code List
liver fibrosis score (metavir)
CL Item
F0 (1)
CL Item
F1 (2)
CL Item
F2 (3)
CL Item
F3 (4)
CL Item
F4 (5)
Item
Inflammation score (metavir)
integer
C3888527 (UMLS CUI [1])
Inflammation score (metavir)
Code List
Inflammation score (metavir)
CL Item
A0 (1)
CL Item
A1 (2)
CL Item
A2 (3)
CL Item
A3 (4)
hepatic steatosis
Item
Is there steatosis?
boolean
C2711227 (UMLS CUI [1])
Item
Hepatic steatosis grade
integer
C2711227 (UMLS CUI [1])
Hepatic steatosis grade
Code List
Hepatic steatosis grade
CL Item
less than 30% (1)
CL Item
30% to 60% (2)
CL Item
more than 60% (3)
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