Phase 3
Completed N=187
A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01674725 ↗
Enrolled (actual)
187
Serious AEs
2.2%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses — 97.7; 100 percentage of participants
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 1b (HCV GT1b) infection without cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses |
97.7; 100 | — |
| SECONDARY Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment |
42.0; 5.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses |
97.7; 100 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment |
0; 0 | — |
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 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
- Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.
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
- Use of contraindicated medications within 2 weeks of dosing
Data sourced from ClinicalTrials.gov (NCT01674725). 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.