ID

14114

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 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

English

VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

1 forms  
Laboratory blood urine pregnancy
Description

Laboratory blood urine pregnancy

Alias
UMLS CUI-1
C0022877
date of collection
Description

date of collection

Data type

integer

Alias
UMLS CUI [1,1]
C1516698
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
remarks regarding sample collection, if any
Description

remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
clinically significant abnormalities?
Description

overall interpretation of laboratory report(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
central laboratory reference number
Description

sample reference numbers

Data type

text

Alias
UMLS CUI [1,1]
C2826265
UMLS CUI [1,2]
C1880016
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Similar models

VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory blood urine pregnancy
C0022877 (UMLS CUI-1)
Item
date of collection
integer
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
date of collection
Code List
date of collection
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])
remarks
Item
remarks regarding sample collection, if any
text
C0947611 (UMLS CUI [1])
abnormality clinically significant
Item
clinically significant abnormalities?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
central laboratory reference number
Item
central laboratory reference number
text
C2826265 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
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