Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)

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

Sponsors

Lead sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief 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.

Overall Status Completed
Start Date February 2015
Completion Date December 2015
Primary Completion Date October 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) Follow-up Week 12
Secondary Outcome
Measure Time Frame
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) Follow-up Weeks 4 and 24
Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)
Enrollment 53
Condition
Intervention

Intervention type: Drug

Intervention name: Daclatasvir

Intervention type: Drug

Intervention name: Sofosbuvir

Intervention type: Drug

Intervention name: Ribavirin

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol - Myers Squibb Study Director Bristol-Myers Squibb
Location
facility
Local Institution | Darlinghurst, New South Wales, 2010, Australia
Local Institution | Greenslopes, Queensland, 4120, Australia
Local Institution | Adelaide, South Australia, 5000, Australia
Local Institution | Clayton, Victoria, 3168, Australia
Local Institution | Fitzroy, Victoria, 3065, Australia
Local Institution | Heidelberg, Victoria, 3084, Australia
Local Institution | Creteil Cedex, 94010, France
Local Institution | Grenoble Cedex 09, 38043, France
Local Institution | Paris Cedex 14, 75679, France
Local Institution | Vandoeuvre Les Nancy, 54511, France
Location Countries

Australia

France

Verification Date

December 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)

Arm group type: Active Comparator

Description: Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing

Arm group label: Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)

Arm group type: Active Comparator

Description: Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov