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

Last updated: July 28, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Hepatitis C; Chronic

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02247401
M14-250
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 infectionOR
  • Treatment Experienced (Prior null responders, Partial responders or Relapsers topegylated-interferon [pegIFN]/RBV);
  • Females must be post-menopausal, of non-child bearing potential or practicing specificforms of birth control
  • In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy orFibroscan
  • In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscanwith Child-Pugh score less than or equal to 6 at Screening and confirmed absence ofhepatocellular carcinoma

Exclusion

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virusantibody
  • HCV genotype performed during screening indicating unable to genotype or co-infectionwith 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 andconfirmed presence of hepatocellular carcinoma

Study Design

Total Participants: 160
Study Start date:
November 04, 2014
Estimated Completion Date:
August 01, 2016

Study 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).

Connect with a study center

  • Site Reference ID/Investigator# 127895

    Cairo, 11559
    Egypt

    Site Not Available

  • Site Reference ID/Investigator# 127941

    Dakahliah,
    Egypt

    Site Not Available

  • Site Reference ID/Investigator# 127899

    Menoufiya, 35111
    Egypt

    Site Not Available

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