A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Phase 2 Completed 50 enrolled AbbVie

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Timeline

Start: 2011-02
Primary completion: 2011-11
Completion: 2012-10

Publications

Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):45-53. doi: 10.1056/NEJMoa1208809.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	paritaprevir	Small molecule	150 mg	Oral
Subject	paritaprevir	Small molecule	250 mg	Oral
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	Oral
Background	dasabuvir	Small molecule	400 mg	Oral

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Summary

Timeline

Publications

Drugs

Indications