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

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 HCV Genotype 3

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02551861

Enrollment

Registered

2015-09-16

Start date

2015-12-31

Completion date

2017-06-30

Last updated

2016-01-15

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

Conditions

Hepatitis C

Brief summary

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.

Interventions

DRUGDaclatasvir

DRUGSofosbuvir

DRUGRibavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)	Post Treatment Follow up Week 12	SVR12 defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy

Secondary

Measure	Time frame
Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing	Approximately 1.5 years
Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm	Post treatment follow up Week 24
Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm	Post Treatment Follow up Week 12

Countries

Canada, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026