Overview

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

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Ribavirin
Ritonavir
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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