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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C Infection, Hepatitis C, Hepatitis C Virus

In brief

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.

Key facts

Study ID

NCT01306617

Run by

AbbVie (prior sponsor, Abbott)

People needed

50

Starts

2011-02-01

Expected to finish

2012-10-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hepatitis C virus (HCV)
• Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
• Males and females 18-65 years old
• Body mass index 18 to < 35 kg/m\^2
• Females must be postmenopausal for at least 2 years or surgically sterile

You may not qualify if…

• Cirrhosis or extensive bridging fibrosis
• History of cardiac disease
• Positive screen for certain drugs or alcohol
• Abnormal laboratory results
• Significant sensitivity to any drug
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
• Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing

Where it is running

• Site Reference ID/Investigator# 48263 — Los Angeles, California, United States
• Site Reference ID/Investigator# 48264 — Aurora, Colorado, United States
• Site Reference ID/Investigator# 51282 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 50425 — Springfield, Massachusetts, United States
• Site Reference ID/Investigator# 50423 — Kansas City, Missouri, United States
• Site Reference ID/Investigator# 48268 — New York, New York, United States
• Site Reference ID/Investigator# 50428 — Statesville, North Carolina, United States
• Site Reference ID/Investigator# 48266 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 50427 — Newport News, Virginia, United States
• Site Reference ID/Investigator# 48265 — Seattle, Washington, United States
• Site Reference ID/Investigator# 50424 — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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