Phase 3
Completed N=395
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01715415 ↗
Enrolled (actual)
395
Serious AEs
2.0%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment — 96.3 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-experienced adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment |
96.3 | — |
| SECONDARY Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period |
96.9; 12.8 | <0.001 sig |
| SECONDARY Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment |
96.0 | — |
| SECONDARY Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment |
96.7 | — |
| 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 |
— | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm |
2.4 | — |
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.
- Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
- 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 (NCT01715415). 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.