Phase 3 N=166 Treatment

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

Hepatitis C Infection · Hepatitis C Virus

Bottom Line

View on ClinicalTrials.gov: NCT02582632 ↗

Enrolled (actual)

166

Serious AEs

1.2%

Results posted

Dec 2017

Primary outcome: Primary: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 97.6 percentage of participants

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	97.6	—
SECONDARY Percentage of Participants With On-Treatment Virologic Failure During Treatment Period	0.6	—
SECONDARY Percentage of Participants With Post-Treatment Relapse12	1.2	—
SECONDARY Percentage of Female Participants Responding With SVR12	97.9	—
SECONDARY Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12	98.1	—

Summary

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

Eligibility Criteria

Inclusion Criteria

Chronic HCV infection at Screening.
Screening laboratory result indicating HCV genotype 1b infection.
Treatment-naïve and non-cirrhotic.

Exclusion Criteria

HCV genotype or subtype other than GT1b.
Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
Any current or past clinical evidence of cirrhosis.
Screening laboratory analyses that shows abnormal results.
Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02582632). 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.