A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
This trial is active, not recruiting.
|Conditions||chronic hepatitis c, hepatitis c virus|
|Treatments||abt-450/r, abt-530, ribavirin (rbv)|
|Start date||June 2013|
|End date||January 2015|
|Trial size||20 participants|
|Trial identifier||NCT02068222, M14-213|
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Dothan, AL||Site Reference ID/Investigator# 124035||no longer recruiting|
|Seattle, WA||Site Reference ID/Investigator# 124036||no longer recruiting|
|San Antonio, TX||Site Reference ID/Investigator# 124037||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
ABT-450/r and ABT-530 co-administered with ribavirin (RBV) for 12 weeks
ABT-450/r and ABT-530 co-administered for 12 weeks
The percentage of subjects who achieve 12-week sustained virologic response (SVR12) in each treatment arm
time frame: 12 weeks after last dose of study drug
The percentage of subjects who achieve 24-week sustained virologic response (SVR24) in each treatment arm
time frame: 24 weeks after last dose of study drug
The percentage of subjects with virologic failure during treatment
time frame: Up to Treatment Week 12
The percentage of subjects with Post-Treatment relapse
time frame: Within 12 weeks after the last dose of study drug
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2. - Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV. - Subject has plasma HCV RNA level > 10,000 IU/mL at Screening. - Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any drug. - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab). - Prior therapy for the treatment of HCV. - Any current or past clinical evidence of cirrhosis. - Any cause of liver disease other than chronic HCV-infection. - HCV genotype co-infection with any other HCV genotype. - Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
|Official title||An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection|
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