Clinical trial NCT02319031: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-12-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
timeFrame: Follow-up Week 12
Secondary outcomes:
measure: Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)
timeFrame: Follow-up Weeks 4 and 24
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Creteil Cedex
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol - Myers Squibb
role: STUDY_DIRECTOR
References: