ID

42013

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. 3/21/16 3/21/16 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Administration of TAC/CsA

English

VX-950HPC3006 NCT01571583 Administration of TAC/CsA

1 forms  
Administration of TAC/CsA
Description

Administration of TAC/CsA

therapy
Description

therapy

Data type

integer

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0085149
UMLS CUI [3]
C0010592
Dose per intake
Description

Dose per intake

Data type

text

Alias
UMLS CUI [1]
C3174092
unit
Description

Unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
frequency
Description

frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
route of administration
Description

route of administration

Data type

integer

Alias
UMLS CUI [1]
C0013153
start of therapy
Description

start of therapy

Data type

date

Alias
UMLS CUI [1]
C3173309
end of therapy
Description

please complete "ongoing" only at the end of the trial

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444930
reason for change
Description

reason for change

Data type

integer

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C1272707
row number
Description

row number

Data type

text

Alias
UMLS CUI [1]
C0237753
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Similar models

VX-950HPC3006 NCT01571583 Administration of TAC/CsA

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration of TAC/CsA
Item
therapy
integer
C0087111 (UMLS CUI [1])
C0085149 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
therapy
Code List
therapy
CL Item
Tacrolimus (1)
CL Item
Cyclosporin A (2)
Dose per intake
Item
Dose per intake
text
C3174092 (UMLS CUI [1])
Item
unit
integer
C1519795 (UMLS CUI [1])
Unit
Code List
unit
CL Item
mg (1)
CL Item
other please specify (2)
frequency
Item
frequency
text
C3476109 (UMLS CUI [1])
Item
route of administration
integer
C0013153 (UMLS CUI [1])
route of administration
Code List
route of administration
CL Item
oral (1)
CL Item
other specify (2)
start of therapy
Item
start of therapy
date
C3173309 (UMLS CUI [1])
Item
end of therapy
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
therapy end
Code List
end of therapy
CL Item
end date please specify (1)
CL Item
ongoing at end of the trial (2)
Item
reason for change
integer
C1299575 (UMLS CUI [1,1])
C1272707 (UMLS CUI [1,2])
reason for change
Code List
reason for change
CL Item
PK (1)
CL Item
AE (2)
CL Item
Other please specify (3)
row number
Item
row number
text
C0237753 (UMLS CUI [1])
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