Phase 3
Completed N=636
A Study to Evaluate Chronic Hepatitis C Infection
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01716585 ↗
Enrolled (actual)
636
Serious AEs
1.5%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment — 96.4 percentage of participants
Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment |
96.4 | — |
| SECONDARY Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period |
97.0; 15.8 | < 0.001 sig |
| SECONDARY Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment |
95.7 | — |
| SECONDARY Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment |
98.0 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm |
0.2 | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm |
1.5 | — |
Eligibility Criteria
Inclusion Criteria
- Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Exclusion Criteria
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Certain predefined abnormal laboratory tests
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Data sourced from ClinicalTrials.gov (NCT01716585). 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.