Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
NCT ID: NCT02319031
Last Updated: 2017-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
53 participants
INTERVENTIONAL
2015-02-28
2015-12-31
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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Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Daclatasvir
Sofosbuvir
Ribavirin
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Daclatasvir
Sofosbuvir
Ribavirin
Interventions
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Daclatasvir
Sofosbuvir
Ribavirin
Eligibility Criteria
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Inclusion Criteria
* Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
* HCV RNA Viral load ≥ 10,000 IU/mL
* HCV Treatment naive or treatment-experienced
Exclusion Criteria
* Non advanced fibrosis or compensated cirrhosis
* Any prior treatment with NS5A inhibitors
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
Darlinghurst, New South Wales, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution
Fitzroy, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Créteil, , France
Local Institution
Grenoble, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Countries
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Study Documents
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Document Type: Primary Publication
View DocumentRelated Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI444-326
Identifier Type: -
Identifier Source: org_study_id
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