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
NCT ID: NCT02551861
Last Updated: 2016-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2015-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daclatasvir + Sofosbuvir
Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks
Daclatasvir
Sofosbuvir
Daclatasvir + Sofosbuvir + Ribavirin
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
Daclatasvir
Sofosbuvir
Ribavirin
Interventions
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Daclatasvir
Sofosbuvir
Ribavirin
Eligibility Criteria
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Inclusion Criteria
* 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
* Previously taken HCV medication
* Liver Cirrhosis
* Evidence of decompensated liver disease
* HIV/ hepatitis B virus (HBV) coinfection
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Créteil, , France
Local Institution
Limoges, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Pessac, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2015-003468-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-377
Identifier Type: -
Identifier Source: org_study_id
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