Phase 3
Completed N=99
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Chronic Hepatitis C · Cirrhosis · Hepatitis C
Source: ClinicalTrials.gov NCT02442284 ↗
Enrolled (actual)
99
Serious AEs
7.1%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 93.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
93.9 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
1.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
2.2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders |
95.8 | — |
Eligibility Criteria
Inclusion Criteria
- US military veteran currently receiving healthcare through the Veterans Health Administration
- Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
- Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
- Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
- Any current or past clinical evidence of Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Data sourced from ClinicalTrials.gov (NCT02442284). 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.