A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
NCT ID: NCT02673489
Last Updated: 2018-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2016-03-15
2017-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
DCV
SOF
RBV
Interventions
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DCV
SOF
RBV
Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥10000 IU (International Unit)/mL
* Compensated Liver Cirrhosis
* BMI 18-40 kg/m2
* Previously treated for HCV or never treated for HCV
Exclusion Criteria
* Evidence of decompensated liver disease
* Previous exposure to 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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Keck Medical Center Of USC
Los Angeles, California, United States
University Of California, San Francisco
San Francisco, California, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Ruth Rothstein Core Center
Chicago, Illinois, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Methodist Transplant Physicians
Dallas, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc
Richmond, Virginia, United States
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Regina, Saskatchewan, Canada
Countries
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References
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Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team. Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C). Antivir Ther. 2019;24(1):35-44. doi: 10.3851/IMP3278.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2015-004331-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-379
Identifier Type: -
Identifier Source: org_study_id
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