NCT01074008

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Detailed description

This was a Phase 2a, randomized, blinded, placebo-controlled, dose-ranging study in chronically, hepatitis C virus (HCV) genotype 1-infected participants designed to explore the safety, tolerability, pharmacokinetics, antiviral activity, as well as the evolution and persistence to resistance of ABT-450/r, ABT-333, or ABT-072. Participants were treated with ABT-450/r, ABT-333, or ABT-072 monotherapy for 3 days, followed by 81 days (12 weeks minus 3 days of monotherapy) of ABT-450/r, ABT-333, or ABT-072 combined with pegylated interferon/ribavirin (pegIFN/RBV), followed by 36 weeks of pegIFN/RBV alone. Participants randomized to an ABT-450/r treatment group who achieved rapid virologic response (RVR) and had HCV ribonucleic acid (RNA) levels \< 25 IU/mL at all subsequent visits were eligible to stop pegIFN/RBV therapy on or after Week 24.

Conditions

• Hepatitis C
• HCV
• Chronic Hepatitis C Infection
• Hepatitis C Genotype 1

Interventions

Type	Name	Description
DRUG	ABT-450	50 mg capsules co-administered with ritonavir
DRUG	ABT-072	50 mg tablet
DRUG	ABT-333	400 mg tablet
DRUG	Ritonavir	100 mg capsules co-administered with ABT-450
DRUG	Peginterferon alpha-2a	Syringe, 180 µg/0.5 mL for subcutaneous injections
DRUG	Ribavirin	200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
OTHER	Placebo	Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2012-01-01
• First posted: 2010-02-24
• Last updated: 2015-01-08
• Results posted: 2015-01-08

Locations

26 sites across 2 countries: United States, Puerto Rico