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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02551861
• Other study ID #: AI444-377
• Secondary ID: 2015-003468-36
• Status: Withdrawn
• Phase: Phase 2
• First received: September 15, 2015
• Last updated: January 14, 2016
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Daclatasvir

• Sofosbuvir

• Ribavirin

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
France	Local Institution	Creteil Cedex
France	Local Institution	Limoges
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Paris Cedex 14
France	Local Institution	Pessac
France	Local Institution	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)	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	Post Treatment Follow up Week 12	No
Secondary	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	Yes
Secondary	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	No
Secondary	Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm		Post Treatment Follow up Week 12	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form