Phase 3
N=380
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
Chronic Hepatitis C Infection · Compensated Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT01704755 ↗Enrolled (actual)
380
Serious AEs
5.3%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment — 91.8; 96.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-450/r/ABT-267, ABT-333 (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment |
91.8; 96.5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm |
91.8; 96.5 | 0.051 |
| SECONDARY Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period |
0.5; 1.7 | — |
| SECONDARY Percentage of Participants With Virologic Relapse After Treatment |
5.9; 0.6 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy 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) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated 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
- Male or female between 18 and 70 years, inclusive, at time of Screening.
- Chronic HCV-infection prior to study enrollment.
- Screening laboratory result indicating HCV genotype 1-infection.
- Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
Exclusion Criteria
- Significant liver disease with any cause other than HCV as the primary cause
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
- Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
- Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
- A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
Data sourced from ClinicalTrials.gov (NCT01704755). 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.