ID

14060

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 Unscheduled Assessment

English

VX-950HPC3006 NCT01571583 Unscheduled Assessment

1 forms  
Unscheduled Assessment
Description

Unscheduled Assessment

Check the assessments to be completed at this unscheduled visit
Description

assessment at unscheduled visit

Data type

integer

Alias
UMLS CUI [1]
C0220825
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C3854240
Was a local lab done at this visit?
Description

(office use only)

Data type

integer

Alias
UMLS CUI [1]
C0022877
UMLS CUI [2]
C0545082
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Similar models

VX-950HPC3006 NCT01571583 Unscheduled Assessment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unscheduled Assessment
Item
Check the assessments to be completed at this unscheduled visit
integer
C0220825 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
assessment at unscheduled visit
Code List
Check the assessments to be completed at this unscheduled visit
CL Item
Vital signs / anthropometric measurements (1)
CL Item
12-lead electrocardiogram (2)
CL Item
physical examination (3)
CL Item
central laboratory (4)
CL Item
PK TVR (5)
CL Item
PK TAC/CsA (6)
CL Item
Biopsy (7)
Item
Was a local lab done at this visit?
integer
C0022877 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
local lab
Code List
Was a local lab done at this visit?
CL Item
local laboratory - blood, urine and pregnancy (1)
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