A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Interferons; Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile

• Subjects must meet one of the following:

• Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR

• Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);

• Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.

• Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.

• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any drug.

• Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.

• Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

• Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.