Phase 2
Completed N=316
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01685203 ↗
Enrolled (actual)
316
Serious AEs
2.9%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment — 90.9; 95.2; 90.0; 100 Percentage of participants — p=0.381
Summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment |
90.9; 95.2; 90.0; 100; 100; 97.9 | 0.381 |
| SECONDARY Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment |
86.4; 92.9; 90.0; 100.0; 100.0; 97.9 | — |
| SECONDARY Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure. |
2.3; 0; 2.5; 0; 0; 0 | — |
| SECONDARY Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse. |
4.8; 0; 7.7; 0; 0; 0 | — |
| SECONDARY Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events |
77.3; 73.8; 80.0; 88.1; 85.7; 85.1 | — |
Eligibility Criteria
Inclusion Criteria
- Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
- Subjects must meet one of the following:
- Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
- Body mass index (BMI) is ≥ 18 to 10,000 IU/mL at Screening
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any drug.
- Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
- Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
- Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
Data sourced from ClinicalTrials.gov (NCT01685203). 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.