Phase 3
N=25
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Chronic Hepatitis C · Hepatitis C (HCV) · Hepatitis C Genotype 1a
Bottom Line
View on ClinicalTrials.gov: NCT02476617 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Sep 2017
Primary outcome: Primary: Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12 — -0.464; -0.148; -0.611; -0.399 Fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ombitasvir/paritaprevir/ritonavir (Drug); dasabuvir (Drug); ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12 |
-0.464; -0.148; -0.611; -0.399; -0.462; -0.168 | — |
Summary
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
- Chronic HCV infection.
- Participants must be non-cirrhotic.
- Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
- Participants must meet specific human leukocyte antigen (HLA) allele requirements.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
- Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
- History of solid organ transplant.
- Screening laboratory analysis that shows abnormal results.
Data sourced from ClinicalTrials.gov (NCT02476617). 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.