Phase 2
Completed N=10
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
Source: ClinicalTrials.gov NCT02068222 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) — 90 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) |
90 | — |
| SECONDARY The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) |
90 | — |
| SECONDARY The Percentage of Subjects With Virologic Failure During Treatment |
10 | — |
| SECONDARY The Percentage of Subjects With Post-Treatment Relapse |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to 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.
Data sourced from ClinicalTrials.gov (NCT02068222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.