Phase 3
N=36
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Chronic Hepatitis C Virus (HCV) Infection
Bottom Line
View on ClinicalTrials.gov: NCT02216422 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ombitasvir/Paritaprevir/Ritonavir (Drug); Dasabuvir (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
100 | — |
| SECONDARY Percentage of Participants With On-Treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-Treatment Relapse |
— | — |
Summary
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
Exclusion Criteria
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- Evidence of current or past Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma
- Abnormal laboratory tests
- Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
- Previous treatment with a direct acting antiviral agent (DAA) containing regimen
- History of solid organ transplant.
Data sourced from ClinicalTrials.gov (NCT02216422). 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.