Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
HCV
Hepatitis C Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
Detailed Description
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).
Eligibility Criteria
Inclusion
- Chronic hepatitis C, genotype 4-infection (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] level greater than 1,000 IU/mL at Screening)
- Subjects must meet one of the following:
- Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon \[pegIFN\]/RBV);
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
- 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
Exclusion
- Females who are pregnant or breastfeeding
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
- abnormal laboratory tests
- self-reports current drinking more than 2 drinks per day
- current enrollment in another investigational study
- previous treatment with a direct acting antiviral agent (DAA) containing regimen
- In substudy 1, evidence of liver cirrhosis
- In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma
Key Trial Info
Start Date :
November 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02247401
Start Date
November 4 2014
End Date
August 1 2016
Last Update
July 30 2021
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