ID

14106

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 or Dermatologist or Digital Pictures

English

VX-950HPC3006 NCT01571583 Biopsy or Dermatologist or Digital Pictures

1 forms  
Biopsy or dermatologist or digital pictures
Description

Biopsy or dermatologist or digital pictures

rash or cutaneous event number
Description

rash or cutaneous event number

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
has the subject been examined by a dermatologist?
Description

please keep a copy of the dermatologist's report with the source documents

Data type

integer

Alias
UMLS CUI [1]
C1141976
has a biopsy been taken?
Description

please keep a copy of the biopsy report with the source documents

Data type

integer

Alias
UMLS CUI [1]
C0005558
were pictures taken?
Description

please keep a copy of the pictures with the source documents

Data type

integer

Alias
UMLS CUI [1]
C0441468
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Similar models

VX-950HPC3006 NCT01571583 Biopsy or Dermatologist or Digital Pictures

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Biopsy or dermatologist or digital pictures
rash or cutaneous event number
Item
rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
has the subject been examined by a dermatologist?
integer
C1141976 (UMLS CUI [1])
dermatologic examination
Code List
has the subject been examined by a dermatologist?
CL Item
yes, please specify date of visit (1)
CL Item
no (2)
Item
has a biopsy been taken?
integer
C0005558 (UMLS CUI [1])
biopsy
Code List
has a biopsy been taken?
CL Item
yes please specify date of visit (1)
CL Item
no (2)
Item
were pictures taken?
integer
C0441468 (UMLS CUI [1])
photo
Code List
were pictures taken?
CL Item
yes, please specify date of visit (1)
CL Item
no (2)
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