Phase 3
N=305
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Chronic Hepatitis C Infection
Bottom Line
View on ClinicalTrials.gov: NCT01833533 ↗Enrolled (actual)
305
Serious AEs
1.3%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses — 97.0; 90.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-450/r/ABT-267, ABT-333 (Drug); Ribavirin (Drug); Placebo for Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses |
97.0; 90.2 | — |
| SECONDARY Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment |
42.0; 3.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses |
97.0; 90.2 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
1.0; 2.9; 0; 0 | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment |
1.0; 5.2 | — |
Summary
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.
Eligibility Criteria
Inclusion Criteria
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Exclusion Criteria
- Significant liver disease with any cause other than HCV as the primary cause
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
Data sourced from ClinicalTrials.gov (NCT01833533). 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.