ID

13837

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. 3/10/16 3/10/16 -
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CC BY-NC 3.0

Uploaded on

March 10, 2016

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Prior treatment history

English

VX-950HPC3006 Prior treatment history

1 forms  
Prior treatment outcome
Description

Prior treatment outcome

Treatment status
Description

Treatment status

Data type

integer

Alias
UMLS CUI [1]
C0749659
If treatment-experienced did the subject receive 80% or more of the intended dosing during the prior treatment?
Description

Prior treatment dose

Data type

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514463
If 80% or more of the intended dosing was received please specify
Description

treatment response

Data type

integer

Alias
UMLS CUI [1]
C0521982
Prior HCV therapy
Description

Prior HCV therapy

Treatment
Description

Treatment

Data type

integer

Alias
UMLS CUI [1]
C0087111
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Date of first dose
Description

Date of first dose

Data type

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Description

Date last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Prior HCV RNA results
Description

Prior HCV RNA results

HCV RNA sample was taken
Description

HCV RNA sample

Data type

integer

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0040223
Date HCV RNA sample taken
Description

Date HCV RNA sample taken

Data type

integer

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0011008
HCV RNA result
Description

HCV RNA result

Data type

integer

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C2826772
quantitative assay result
Description

Quantitative assay result

Data type

integer

Alias
UMLS CUI [1,1]
C1510438
UMLS CUI [1,2]
C0392762
UMLS CUI [1,3]
C2826772
If detectable quantitative assay
Description

detectable quantitative assay

Data type

text

Alias
UMLS CUI [1,1]
C1510438
UMLS CUI [1,2]
C0392762
UMLS CUI [1,3]
C3830527
qualitative assay result
Description

qualitative assay

Data type

integer

Alias
UMLS CUI [1,1]
C1510438
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2826772
Assay specify
Description

Assay

Data type

integer

Alias
UMLS CUI [1]
C1510438
Limit of detection
Description

Limit of detection

Data type

text

Alias
UMLS CUI [1]
C2718050
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Similar models

VX-950HPC3006 Prior treatment history

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Prior treatment outcome
Item
Treatment status
integer
C0749659 (UMLS CUI [1])
Treatment status
Code List
Treatment status
CL Item
Treatment Naïve (1)
CL Item
Treatment-Experienced (2)
Prior treatment dose
Item
If treatment-experienced did the subject receive 80% or more of the intended dosing during the prior treatment?
boolean
C3174092 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Item
If 80% or more of the intended dosing was received please specify
integer
C0521982 (UMLS CUI [1])
treatment response
Code List
If 80% or more of the intended dosing was received please specify
CL Item
Prior null responder (1)
CL Item
Prior partial responder (2)
CL Item
prior relapser (3)
CL Item
other please specify (4)
Item Group
Prior HCV therapy
Item
Treatment
integer
C0087111 (UMLS CUI [1])
Treatment
Code List
Treatment
CL Item
Peg-IFN 2a (1)
CL Item
Peg-IFN 2b (2)
CL Item
ALB-IFN (3)
CL Item
RBV (4)
CL Item
Other please specify (5)
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Item
Unit
integer
C1519795 (UMLS CUI [1])
Unit
Code List
Unit
CL Item
mg (1)
CL Item
microg (2)
CL Item
Other please specify (3)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
once daily (1)
CL Item
twice daily (2)
CL Item
weekly (3)
CL Item
other specify (4)
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Item Group
Prior HCV RNA results
Item
HCV RNA sample was taken
integer
C0369335 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
HCV RNA sample
Code List
HCV RNA sample was taken
CL Item
before start of prior treatment (1)
CL Item
12 weeks after start of prior treatment (2)
CL Item
during prior treatment (3)
CL Item
at end of prior treatment (4)
CL Item
during follow-up after prior treatment (5)
Item
Date HCV RNA sample taken
integer
C0369335 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date HCV RNA sample taken
Code List
Date HCV RNA sample taken
CL Item
Date (1)
CL Item
Sample not available (2)
Item
HCV RNA result
integer
C0369335 (UMLS CUI [1,1])
C2826772 (UMLS CUI [1,2])
HCV RNA result
Code List
HCV RNA result
CL Item
quantitative assay result (1)
CL Item
qualitative assay result (2)
Item
quantitative assay result
integer
C1510438 (UMLS CUI [1,1])
C0392762 (UMLS CUI [1,2])
C2826772 (UMLS CUI [1,3])
Quantitative assay
Code List
quantitative assay result
CL Item
detectable (1)
CL Item
undetectable (2)
detectable quantitative assay
Item
If detectable quantitative assay
text
C1510438 (UMLS CUI [1,1])
C0392762 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
Item
qualitative assay result
integer
C1510438 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2826772 (UMLS CUI [1,3])
qualitative assay
Code List
qualitative assay result
CL Item
detectable (1)
CL Item
undetectable (2)
Item
Assay specify
integer
C1510438 (UMLS CUI [1])
Assay
Code List
Assay specify
CL Item
RDC Assay (1)
CL Item
Other specify (2)
Limit of detection
Item
Limit of detection
text
C2718050 (UMLS CUI [1])
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