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



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:April 2014
End Date:March 2015

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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

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.


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.
We found this trial at
3
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618
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Dothan, AL
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1144
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San Antonio, TX
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2005
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Seattle, WA
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