ID

14121

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 Local Laboratory [FRMLB_LOCLABUNS1]

English

VX-950HPC3006 NCT01571583 Local Laboratory [FRMLB_LOCLABUNS1]

1 forms  
Date of sampling
Description

Date of sampling

Alias
UMLS CUI-1
C0870078
UMLS CUI-2
C0011008
date and time of collection
Description

collection date

Data type

integer

Alias
UMLS CUI [1]
C1317250
if other date please specify
Description

other date

Data type

date

local laboratory name
Description

local laboratory name

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1301943
remarks regarding sample collection, if any
Description

remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
clinically significant results
Description

clinically significant results

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Local laboratory results entry
Description

Local laboratory results entry

lab method
Description

lab method

Data type

integer

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C1881193
UMLS CUI [3]
C0201916
UMLS CUI [4]
C0373670
UMLS CUI [5]
C0201883
UMLS CUI [6]
C0202035
value
Description

value

Data type

text

Alias
UMLS CUI [1]
C1522609
unit
Description

unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
if other unit please specify
Description

other unit

Data type

text

Alias
UMLS CUI [1]
C1519795
normal range lower limit
Description

please ensure the unit is the same as the unit for the value

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C2827739
normal range upper limit
Description

please ensure the unit is the same as the unit for the value

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C1519815
normal range - text based
Description

please ensure the unit is the same as the unit for the value

Data type

text

Alias
UMLS CUI [1]
C0086715
row number
Description

(for office use only)

Data type

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Local Laboratory [FRMLB_LOCLABUNS1]

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of sampling
C0870078 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item
date and time of collection
integer
C1317250 (UMLS CUI [1])
collection date
Code List
date and time 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
local laboratory name
Item
local laboratory name
text
C0022877 (UMLS CUI [1,1])
C1301943 (UMLS CUI [1,2])
remarks
Item
remarks regarding sample collection, if any
text
C0947611 (UMLS CUI [1])
clinically significant results
Item
clinically significant results
boolean
C2826633 (UMLS CUI [1])
Item Group
Local laboratory results entry
Item
lab method
integer
C1278039 (UMLS CUI [1])
C1881193 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
C0373670 (UMLS CUI [4])
C0201883 (UMLS CUI [5])
C0202035 (UMLS CUI [6])
lab method
Code List
lab method
CL Item
bilirubin total (1)
CL Item
direct bilirubin (2)
CL Item
indirect bilirubin (3)
CL Item
lipase (4)
CL Item
pancreatic amylase (5)
CL Item
GGT (6)
CL Item
other please specify (7)
value
Item
value
text
C1522609 (UMLS CUI [1])
Item
unit
integer
C1519795 (UMLS CUI [1])
unit
Code List
unit
CL Item
10^9/L (1)
CL Item
Cells/10**9/L (2)
CL Item
Cells/microliter (3)
CL Item
mm^3 (4)
CL Item
Cells/m**3 (5)
CL Item
% (6)
CL Item
mmol/L (7)
CL Item
micromol/L (8)
CL Item
IU/L (9)
CL Item
g/L (10)
CL Item
g/dL (11)
CL Item
mg/dl (12)
CL Item
microliter (13)
CL Item
mm/hr (14)
CL Item
other please sepcify (15)
other unit
Item
if other unit please specify
text
C1519795 (UMLS CUI [1])
normal range lower limit
Item
normal range lower limit
text
C0086715 (UMLS CUI [1,1])
C2827739 (UMLS CUI [1,2])
normal range upper limit
Item
normal range upper limit
text
C0086715 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
normal range
Item
normal range - text based
text
C0086715 (UMLS CUI [1])
row number
Item
row number
text
C0237753 (UMLS CUI [1])
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