Clinical trial NCT02551861: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
timeFrame: Post Treatment Follow up Week 12
Secondary outcomes:
measure: 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
timeFrame: Approximately 1.5 years
measure: 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
timeFrame: Post treatment follow up Week 24
measure: Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm
timeFrame: Post Treatment Follow up Week 12
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Creteil Cedex
country: France
facility: Local Institution
city: Limoges
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: