ID

44060

Description

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt; ODM derived from: https://clinicaltrials.gov/show/NCT02247401

Link

https://clinicaltrials.gov/show/NCT02247401

Keywords

Versions (2)
  1. 4/1/19 4/1/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility HCV NCT02247401

English

Eligibility HCV NCT02247401

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility HCV NCT02247401
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 4-infection (hcv rna level greater than 1,000 iu/ml at screening)
Description

Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0009450
UMLS CUI [3]
C1272251
subjects must meet one of the following:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
Description

Therapy naive | Antiviral Therapy Absent Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
Description

PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Partial responder to therapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C1875630
UMLS CUI [2]
C0919875
UMLS CUI [3]
C1740822
UMLS CUI [4]
C0277556
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
Description

Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
in substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or fibroscan
Description

Study Specified | Liver Cirrhosis Absent Biopsy of liver | Liver Cirrhosis Absent Fibroscan

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C4522043
in substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or fibroscan with child-pugh score less than or equal to 6 at screening and confirmed absence of hepatocellular carcinoma
Description

Study Specified | Liver Cirrhosis Biopsy of liver | Liver Cirrhosis Fibroscan | Liver Cirrhosis Child-Pugh Classification | Liver carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0193388
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C4522043
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C4050412
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
Description

Hepatitis B surface antigen positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
hcv genotype performed during screening indicating unable to genotype or co-infection with any other hcv genotype
Description

Hepatitis C virus genotype determination

Data type

boolean

Alias
UMLS CUI [1]
C1533728
abnormal laboratory tests
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
self-reports current drinking more than 2 drinks per day
Description

Alcohol consumption Drink per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
current enrollment in another investigational study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
previous treatment with a direct acting antiviral agent (daa) containing regimen
Description

DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1]
C3653501
in substudy 1, evidence of liver cirrhosis
Description

Study Specified | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0023890
in substudy 2, evidence of current or past child-pugh b or c classification and confirmed presence of hepatocellular carcinoma
Description

Study Specified | Child-Pugh Classification | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C2603343
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C4050412
UMLS CUI [3]
C2239176
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Similar models

Eligibility HCV NCT02247401

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility HCV NCT02247401
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay
Item
chronic hepatitis c, genotype 4-infection (hcv rna level greater than 1,000 iu/ml at screening)
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
Criteria Fulfill
Item
subjects must meet one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Therapy naive | Antiviral Therapy Absent Hepatitis C
Item
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Partial responder to therapy | Recurrent disease
Item
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
boolean
C1875630 (UMLS CUI [1])
C0919875 (UMLS CUI [2])
C1740822 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods
Item
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Study Specified | Liver Cirrhosis Absent Biopsy of liver | Liver Cirrhosis Absent Fibroscan
Item
in substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or fibroscan
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
Study Specified | Liver Cirrhosis Biopsy of liver | Liver Cirrhosis Fibroscan | Liver Cirrhosis Child-Pugh Classification | Liver carcinoma Absent
Item
in substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or fibroscan with child-pugh score less than or equal to 6 at screening and confirmed absence of hepatocellular carcinoma
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0023890 (UMLS CUI [3,1])
C4522043 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Hepatitis C virus genotype determination
Item
hcv genotype performed during screening indicating unable to genotype or co-infection with any other hcv genotype
boolean
C1533728 (UMLS CUI [1])
Laboratory test result abnormal
Item
abnormal laboratory tests
boolean
C0438215 (UMLS CUI [1])
Alcohol consumption Drink per day
Item
self-reports current drinking more than 2 drinks per day
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Study Subject Participation Status
Item
current enrollment in another investigational study
boolean
C2348568 (UMLS CUI [1])
DIRECT ACTING ANTIVIRALS
Item
previous treatment with a direct acting antiviral agent (daa) containing regimen
boolean
C3653501 (UMLS CUI [1])
Study Specified | Liver Cirrhosis
Item
in substudy 1, evidence of liver cirrhosis
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
Study Specified | Child-Pugh Classification | Liver carcinoma
Item
in substudy 2, evidence of current or past child-pugh b or c classification and confirmed presence of hepatocellular carcinoma
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C4050412 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
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