NCT01464827

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

Detailed description

A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

Conditions

• Chronic Hepatitis C
• Hepatitis C (HCV)
• Hepatitis C Genotype 1

Interventions

Type	Name	Description
DRUG	ABT-450	ABT-450 tablets
DRUG	ABT-333	ABT-333 tablets
DRUG	ABT-267	ABT-267 tablets
DRUG	Ribavirin	Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
DRUG	Ritonavir	Ritonavir capsules

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-03-01
• Completion: 2013-09-01
• First posted: 2011-11-04
• Last updated: 2015-04-22
• Results posted: 2015-01-06

Locations

97 sites across 9 countries: United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom