Safety and Efficacy Study of Daclatasvir 60mg, Sofosbuvir 400mg, and Ribavarin (dosed based upon weight) in subjects with chronic Genotype 3 Hepatitis C infection with or without prior treatment experience and compensated advanced cirrhosis for 12 or 16 weeks.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005310-28-FR

Enrollment

Registered

2015-06-24

Start date

2015-02-13

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genotype 3 Chronic Hepatitis C infection with Compensated Advanced Fibrosis/Cirrhosis (F3/F4) MedDRA version: 18.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Daclatasvir Product Code: BMS-790052 / DCV Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DACLATASVIR CAS Number: 1009119-64-5 Current Sponsor code: BMS-790052 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Must have Genotype 3 Chronic HCV - Must have compensated advanced cirrhosis based upon laboratory tests - HCV RNA Viral load = 10,000 IU/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Non Genotype 3 or mixed génotypes - Non Cirrhotics - Any prior treatment with NS5A inhibitors

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavarin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.;Secondary Objective: - To assess safety, as measured by the frequency of deaths, serious adverse events (SAEs), discontinuation due to adverse events (AEs), Grade 3/4 AEs and Grade 3/4 lab abnormalities observed from clinical laboratory testing. - To assess antiviral activity as measured by the proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at post-treatment Weeks 4 and 24;Primary end point(s): Proporation of patients with Sustained Virologic Response (SVR12) defined as HCV RNA < the lower limit of quantification (LLOQ) or undetected HCV RNA at 12 weeks off treatment;Timepoint(s) of evaluation of this end point: 12 weeks after the subject’s last treatment	—

Measure

Time frame

Main Objective: The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavarin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.;Secondary Objective: - To assess safety, as measured by the frequency of deaths, serious adverse events (SAEs), discontinuation due to adverse events (AEs), Grade 3/4 AEs and Grade 3/4 lab abnormalities observed from clinical laboratory testing. - To assess antiviral activity as measured by the proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at post-treatment Weeks 4 and 24;Primary end point(s): Proporation of patients with Sustained Virologic Response (SVR12) defined as HCV RNA < the lower limit of quantification (LLOQ) or undetected HCV RNA at 12 weeks off treatment;Timepoint(s) of evaluation of this end point: 12 weeks after the subject’s last treatment

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Secondary

Measure	Time frame
Secondary end point(s): - On treatment safety, as measured by frequency of Serious Adverse Events (SAE), discontinuations due to Adverse Events, and laboratory abnormalities through the end of treatment plus 7 days; - Proportion of patients who achieve HCV RNA < the lower limit of quantification (LLOQ) or undetected HCV RNA at 4 (SVR4) and 24 (SVR24) weeks off treatment. ;Timepoint(s) of evaluation of this end point: Entire on treatment period, 12 or 16 weeks, and 4 and 24 weeks after the subject’s last treatment.	—

Measure

Time frame

Secondary end point(s): - On treatment safety, as measured by frequency of Serious Adverse Events (SAE), discontinuations due to Adverse Events, and laboratory abnormalities through the end of treatment plus 7 days; - Proportion of patients who achieve HCV RNA < the lower limit of quantification (LLOQ) or undetected HCV RNA at 4 (SVR4) and 24 (SVR24) weeks off treatment. ;Timepoint(s) of evaluation of this end point: Entire on treatment period, 12 or 16 weeks, and 4 and 24 weeks after the subject’s last treatment.

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Countries

Australia, France

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026