ID

14013

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 (2)
  1. 3/22/16 3/22/16 -
  2. 3/22/16 3/22/16 -
Uploaded on

March 22, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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VX-950HPC3006 NCT01571583 Administration of Ribavirin

English

VX-950HPC3006 NCT01571583 Administration of Ribavirin

1 forms  
Administration of Ribavirin
Description

Administration of Ribavirin

start date
Description

start date

Data type

date

Alias
UMLS CUI [1]
C0808070
end date
Description

end date

Data type

date

Alias
UMLS CUI [1]
C0806020
total daily dose
Description

total daily dose

Data type

text

Measurement units
  • mg
Alias
UMLS CUI [1]
C2348070
mg
frequency
Description

frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
reason for change
Description

in case the subject permanently discontinues from RBV please complete the Drug Term RBV form in visit Drug Term

Data type

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0392360
row number
Description

(for office use only)

Data type

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Administration of Ribavirin

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration of Ribavirin
start date
Item
start date
date
C0808070 (UMLS CUI [1])
end date
Item
end date
date
C0806020 (UMLS CUI [1])
total daily dose
Item
total daily dose
text
C2348070 (UMLS CUI [1])
Item
frequency
integer
C3476109 (UMLS CUI [1])
frequency
Code List
frequency
CL Item
b.i.d. - twice daily (1)
CL Item
other, please specify (2)
Item
reason for change
integer
C1299575 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for change
Code List
reason for change
CL Item
AE (1)
CL Item
weight change (2)
CL Item
other specify (3)
row number
Item
row number
text
C0237753 (UMLS CUI [1])
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