ID

13836

Beschrijving

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

Trefwoorden

Versies (2)
  1. 10-03-16 10-03-16 -
  2. 10-03-16 10-03-16 -
Geüploaded op

10 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Liver Disease History

Engels

VX-950HPC3006 Liver Disease History

1 Formulieren  
Liver Disease History
Beschrijving

Liver Disease History

Date of HCV Infection
Beschrijving

Date of HCV Infection

Datatype

date

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0011008
Date of diagnosis
Beschrijving

Date of diagnosis

Datatype

date

Alias
UMLS CUI [1]
C2316983
Date of liver transplant
Beschrijving

Date of liver transplant

Datatype

date

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0011008
Liver Graft Biopsy Result
Beschrijving

Liver Graft Biopsy Result

Date of biopsy
Beschrijving

Date of biopsy

Datatype

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Did the subject show a stable stage of hepatic fibrosis over the past 3 years prior to the screening visit, as assessed by serial liver graft biopsies during this peior?
Beschrijving

liver fibrosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0239946
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0040223
UMLS CUI [2]
C0193388
liver fibrosis score (metavir)
Beschrijving

liver fibrosis score (metavir)

Datatype

integer

Alias
UMLS CUI [1]
C3897040
Inflammation score (metavir)
Beschrijving

Inflammation score (metavir)

Datatype

integer

Alias
UMLS CUI [1]
C3888527
Is there steatosis?
Beschrijving

If yes, please specify in the following item

Datatype

boolean

Alias
UMLS CUI [1]
C2711227
Hepatic steatosis grade
Beschrijving

Hepatic steatosis grade

Datatype

integer

Alias
UMLS CUI [1]
C2711227
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Similar models

VX-950HPC3006 Liver Disease History

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Liver Disease History
Date of HCV Infection
Item
Date of HCV Infection
date
C0019196 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of diagnosis
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1])
Date of liver transplant
Item
Date of liver transplant
date
C0023911 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Liver Graft Biopsy Result
Date of biopsy
Item
Date of biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
liver fibrosis
Item
Did the subject show a stable stage of hepatic fibrosis over the past 3 years prior to the screening visit, as assessed by serial liver graft biopsies during this peior?
boolean
C0239946 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0193388 (UMLS CUI [2])
Item
liver fibrosis score (metavir)
integer
C3897040 (UMLS CUI [1])
liver fibrosis score
Code List
liver fibrosis score (metavir)
CL Item
F0 (1)
CL Item
F1 (2)
CL Item
F2 (3)
CL Item
F3 (4)
CL Item
F4 (5)
Item
Inflammation score (metavir)
integer
C3888527 (UMLS CUI [1])
Inflammation score (metavir)
Code List
Inflammation score (metavir)
CL Item
A0 (1)
CL Item
A1 (2)
CL Item
A2 (3)
CL Item
A3 (4)
hepatic steatosis
Item
Is there steatosis?
boolean
C2711227 (UMLS CUI [1])
Item
Hepatic steatosis grade
integer
C2711227 (UMLS CUI [1])
Hepatic steatosis grade
Code List
Hepatic steatosis grade
CL Item
less than 30% (1)
CL Item
30% to 60% (2)
CL Item
more than 60% (3)
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