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
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)
1 other identifier
interventional
53
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2015
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedJanuary 27, 2017
December 1, 2016
8 months
December 12, 2014
December 5, 2016
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Follow-up Week 12
Secondary Outcomes (2)
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)
Study Arms (2)
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
ACTIVE COMPARATOROral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
ACTIVE COMPARATOROral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Non Genotype 3 or mixed genotypes
- Non advanced fibrosis or compensated cirrhosis
- Any prior treatment with NS5A inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
Créteil, 94010, France
Local Institution
Grenoble, 38043, France
Local Institution
Paris, 75679, France
Local Institution
Vandœuvre-lès-Nancy, 54511, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol - Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2014
First Posted
December 18, 2014
Study Start
February 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-12