ID

14016

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. 3/22/16 3/22/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 22, 2016

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

English

VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

1 forms  
Dispensation of Telaprevir
Description

Dispensation of Telaprevir

Visit number
Description

Visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Date of kit allocation
Description

Date of kit allocation

Data type

date

Alias
UMLS CUI [1,1]
C1706778
UMLS CUI [1,2]
C0011008
Kit number assigned by IWRS
Description

Kit number assigned by IWRS

Data type

text

Alias
UMLS CUI [1]
C0237753
Kit number from medication tear off label to be dispensed to subject
Description

Kit number from medication tear off label to be dispensed to subject

Data type

text

Alias
UMLS CUI [1]
C0237753
Was this kit assigned by IWRS dispensed to the subject?
Description

kit assigned by IWRS dispensed

Data type

integer

Date of dispensation
Description

Date of dispensation

Data type

integer

Alias
UMLS CUI [1]
C0011008
Number of tablets taken by subject
Description

Number of tablets

Data type

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Kit number returned by subject to site
Description

Kit number

Data type

integer

Alias
UMLS CUI [1]
C0237753
Date when kit was returned by subject to site
Description

Date when kit was returned by subject to site

Data type

date

Alias
UMLS CUI [1]
C0011008
Number of tablets in kit returned by subject to site
Description

Number of tablets in kit

Data type

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
Office use only
Description

Office use only

Data type

text

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Similar models

VX-950HPC3006 NCT01571583 Dispensation of Telaprevir

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dispensation of Telaprevir
Visit number
Item
Visit number
text
C1549755 (UMLS CUI [1])
Date of kit allocation
Item
Date of kit allocation
date
C1706778 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Kit number assigned by IWRS
Item
Kit number assigned by IWRS
text
C0237753 (UMLS CUI [1])
Kit number from medication tear off label to be dispensed to subject
Item
Kit number from medication tear off label to be dispensed to subject
text
C0237753 (UMLS CUI [1])
Item
Was this kit assigned by IWRS dispensed to the subject?
integer
undefined item
Code List
Was this kit assigned by IWRS dispensed to the subject?
CL Item
Yes (1)
CL Item
No, misallocated (please contact monitor immediately) (2)
CL Item
No, study medication discontinued (3)
CL Item
No, kit not available at site (please contact IWRS for new kit assignment) (4)
CL Item
No, other please specify (5)
Item
Date of dispensation
integer
C0011008 (UMLS CUI [1])
Date of dispensation
Code List
Date of dispensation
CL Item
Same as date of kit allocation by IWRS (1)
CL Item
other, specify: (2)
Number of tablets
Item
Number of tablets taken by subject
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Kit number returned by subject to site
integer
C0237753 (UMLS CUI [1])
Kit number
Code List
Kit number returned by subject to site
CL Item
kit number: (1)
CL Item
N/A (kit never returned) (2)
Date when kit was returned by subject to site
Item
Date when kit was returned by subject to site
date
C0011008 (UMLS CUI [1])
Number of tablets in kit
Item
Number of tablets in kit returned by subject to site
text
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Office use only
Item
Office use only
text
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