A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Phase 2 Completed 11 enrolled AbbVie

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Timeline

Start: 2010-10
Primary completion: 2011-05
Completion: 2012-04

Publications

Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABT-072	Small molecule	400 mg	—
Subject	Ribavirin	Small molecule	1000 mg	—
Subject	Ribavirin	Small molecule	1200 mg	—
Subject	paritaprevir	Small molecule	150 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Summary

Timeline

Publications

Drugs

Indications