Phase 3 N=105 Treatment

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Hepatitis C Virus (HCV)

Bottom Line

View on ClinicalTrials.gov: NCT02609659 ↗

Enrolled (actual)

105

Serious AEs

2.9%

Results posted

Oct 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 89.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug); ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	89.5	—
PRIMARY Percentage of Participants With Hemoglobin < 10 g/dL During Treatment	—	—
PRIMARY Mean Change in Hemoglobin Values From Baseline to End of Treatment	-6.4; -8.9; -11.2; -12.4; -12.1	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure	1.0	—
SECONDARY Percentage of Participants With Post-treatment Relapse	4.1	—

Summary

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Eligibility Criteria

Inclusion Criteria

Chronic hepatitis C virus (HCV) infection
Non-cirrhotic subjects
Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion Criteria

Pregnant or breastfeeding women
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
HCV genotype of any subtype other than GT1a or unable to subtype
Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02609659). 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.