A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

January 14, 2016 updated by: Bristol-Myers Squibb

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 2S2
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Local Institution
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3P9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Local Institution
  • France
      • Creteil Cedex, France, 94010
        • Local Institution
      • Limoges, France, 87042
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Genotype 3
  • HCV RNA < 2000000 IU/mL
  • Never taken HCV medication
  • Absence of advanced fibrosis or cirrhosis
  • Body mass index (BMI) 18-40 kg/m^2

Exclusion Criteria:

  • Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
  • Previously taken HCV medication
  • Liver Cirrhosis
  • Evidence of decompensated liver disease
  • HIV/ hepatitis B virus (HBV) coinfection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Daclatasvir + Sofosbuvir
Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks
Drug: Sofosbuvir
Drug: Daclatasvir
Active Comparator: Daclatasvir + Sofosbuvir + Ribavirin
Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
Drug: Sofosbuvir
Drug: Ribavirin
Drug: Daclatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
Time Frame: Post Treatment Follow up Week 12
SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy
Post Treatment Follow up Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing
Time Frame: Approximately 1.5 years
Approximately 1.5 years
Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm
Time Frame: Post treatment follow up Week 24
Post treatment follow up Week 24
Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm
Time Frame: Post Treatment Follow up Week 12
Post Treatment Follow up Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-377
  • 2015-003468-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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