ID

13711

Description

A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01466790

Link

https://clinicaltrials.gov/show/NCT01466790

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01466790

English

Eligibility Hepatitis C NCT01466790

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic genotype 1 hepatitis c virus (hcv) infection
Description

chronic hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C0524910
plasma hcv rna of more than 10,000 iu/ml at screening
Description

plasma hepatitis c virus rna

Data type

boolean

Alias
UMLS CUI [1]
C1977893
patients in cohort 1 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks
Description

therapy ribavirin; therapy response for hepatitis c virus infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0035525
UMLS CUI [2]
C2750389
patients in cohort 2 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks and could also be hcv treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of hcv
Description

therapy response for hepatitis c virus infection; Therapy naive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C2750389
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0019196
null responders patients in cohort 1 and cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 iu/ml reduction in hcv rna from baseline at week 12 of the most recent pegifn/ribavirin therapy
Description

hepatitis c virus; cohort; no response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C0220847
UMLS CUI [2]
C0599755
UMLS CUI [3]
C0184782
patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed metavir f3 or f4 fibrosis
Description

liver biopsy; screening; metavir fibrosis score

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0220908
UMLS CUI [3]
C3897040
must agree to use 2 forms of effective contraception throughout the study (male and female)
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has evidence of hepatic decompensation
Description

hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C0085605
has any liver disease of non-hcv etiology
Description

liver disease; etiology

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1314792
has an infection/co-infection with non-genotype 1 hcv
Description

HCV coinfection; hcv genotype

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C1148363
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibody test at screening)
Description

coinfection hiv; hiv antibody test

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2229753
has a co-infection with hepatitis b virus (hepatitis b surface antigen [hbsag] positive)
Description

HBV coinfection; Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C0149709
has a history of malignancy within 5 years of the screening visit
Description

medical history malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
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Similar models

Eligibility Hepatitis C NCT01466790

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
chronic hepatitis c
Item
chronic genotype 1 hepatitis c virus (hcv) infection
boolean
C0524910 (UMLS CUI [1])
plasma hepatitis c virus rna
Item
plasma hcv rna of more than 10,000 iu/ml at screening
boolean
C1977893 (UMLS CUI [1])
therapy ribavirin; therapy response for hepatitis c virus infection
Item
patients in cohort 1 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks
boolean
C0087111 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C2750389 (UMLS CUI [2])
therapy response for hepatitis c virus infection; Therapy naive Hepatitis C
Item
patients in cohort 2 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks and could also be hcv treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of hcv
boolean
C2750389 (UMLS CUI [1])
C0919936 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
hepatitis c virus; cohort; no response to treatment
Item
null responders patients in cohort 1 and cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 iu/ml reduction in hcv rna from baseline at week 12 of the most recent pegifn/ribavirin therapy
boolean
C0220847 (UMLS CUI [1])
C0599755 (UMLS CUI [2])
C0184782 (UMLS CUI [3])
liver biopsy; screening; metavir fibrosis score
Item
patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed metavir f3 or f4 fibrosis
boolean
C0193388 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C3897040 (UMLS CUI [3])
contraception
Item
must agree to use 2 forms of effective contraception throughout the study (male and female)
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hepatic decompensation
Item
has evidence of hepatic decompensation
boolean
C0085605 (UMLS CUI [1])
liver disease; etiology
Item
has any liver disease of non-hcv etiology
boolean
C0023895 (UMLS CUI [1])
C1314792 (UMLS CUI [2])
HCV coinfection; hcv genotype
Item
has an infection/co-infection with non-genotype 1 hcv
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
coinfection hiv; hiv antibody test
Item
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibody test at screening)
boolean
C0019682 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2229753 (UMLS CUI [2])
HBV coinfection; Hepatitis B surface antigen positive
Item
has a co-infection with hepatitis b virus (hepatitis b surface antigen [hbsag] positive)
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
medical history malignancy
Item
has a history of malignancy within 5 years of the screening visit
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
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