Clinical trial NCT02247401: 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
Official title: An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HCV
Hepatitis C Infection
Genotype 4
Keywords: Genotype 4
non-responder
treatment experienced
HCV
naive
relapser
hepatitis infection
compensated cirrhosis
hepatitis c
Cirrhosis
Egypt
null responder
partial responder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
timeFrame: 12 weeks after last dose
measure: Number of Participants With Adverse Events
timeFrame: Screening until 30 days after last dose
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
timeFrame: Up to 12 or 24 weeks after first dose
measure: Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
timeFrame: Up to 12 weeks after first dose
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarah Kopecky-Bromberg, PhD
role: STUDY_DIRECTOR
References:
citation: Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16.