CompletedPhase 3

Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis

Australia53 participantsStarted 2015-02

Plain-language summary

The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must have Genotype 3 Chronic HCV * Must have advanced fibrosis (F3) or compensated cirrhosis (F4) * HCV RNA Viral load ≥ 10,000 IU/mL * HCV Treatment naive or treatment-experienced Exclusion Criteria: * Non Genotype 3 or mixed genotypes * Non advanced fibrosis or compensated cirrhosis * Any prior treatment with NS5A inhibitors

What they're measuring

Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)

Timeframe: Follow-up Week 12

Trial details

NCT IDNCT02319031

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2016-12-05

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