Overview

This trial is active, not recruiting.

Condition chronic hepatitis c infection
Treatments ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
Phase phase 3
Sponsor AbbVie
Start date October 2015
End date December 2016
Trial size 100 participants
Trial identifier NCT02609659, M15-582

Summary

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) + Ribavirin (600 mg QD) for 12 weeks
ombitasvir/paritaprevir/ritonavir ABT-267/ABT-450/r
Tablet; Ombitasvir co-formulated with Paritaprevir and Ritonavir
dasabuvir ABT-333
Tablet
ribavirin
Tablet

Primary Outcomes

Measure
Percentage of Participants Achieving a 12-week Sustained Virologic Response (SVR12) Post-treatment
time frame: 12 weeks after last dose of study drug
Number of Participants with Hemoglobin less than 10 g/dL
time frame: Baseline (Day 1) and Treatment Weeks 2, 4, 8 and 12

Secondary Outcomes

Measure
Percentage of Participants with On-treatment Virologic Failure
time frame: Up to 12 weeks while on treatment
Percentage of Participants with Post-treatment Relapse
time frame: Between end of treatment (Week 12) and post-treatment (up to Week 24 post-treatment)

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: - Chronic HCV infection - Non-cirrhotic subjects - Screening laboratory results showing HCV Genotype 1a infection - HCV treatment-naïve or if treated previously, only with IFN or pegINF with or without 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 1a 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.

Additional Information

Official title An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.