A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02551861

AI444-377

2015-003468-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Genotype 3
• HCV RNA < 2000000 IU/mL
• Never taken HCV medication
• Absence of advanced fibrosis or cirrhosis
• Body mass index (BMI) 18-40 kg/m^2

Exclusion Criteria:

• Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
• Previously taken HCV medication
• Liver Cirrhosis
• Evidence of decompensated liver disease
• HIV/ hepatitis B virus (HBV) coinfection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Daclatasvir + Sofosbuvir

Active Comparator group

Description:

Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir

Daclatasvir + Sofosbuvir + Ribavirin

Active Comparator group

Description:

Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks

Treatment:

Drug: Sofosbuvir

Drug: Daclatasvir

Drug: Ribavirin