ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage

• Chronic hepatitis C virus (HCV) infection prior to study enrollment.

• Screening laboratory result indicating HCV subtype 1b (GT1b) infection.

• Per local standard practice, documented absence of cirrhosis.

• Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser

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

Exclusion Criteria:

• HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.

• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.

• Any current or past clinical evidence of cirrhosis.

• Any primary cause of liver disease other than chronic HCV infection.

• Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.