A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: RBV; Drug: DCV; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02673489

2015-004331-12 (EudraCT Number)

AI444-379

Details and patient eligibility

About

The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Genotype 3 HCV
• HCV RNA ≥10000 IU (International Unit)/mL
• Compensated Liver Cirrhosis
• BMI 18-40 kg/m2
• Previously treated for HCV or never treated for HCV

Exclusion Criteria:

• Infection with HCV other than Genotype 3. Mixed infection of any genotype
• Evidence of decompensated liver disease
• Previous exposure to NS5A inhibitors

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)

Experimental group

Description:

Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: DCV