A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
2 other identifiers
interventional
106
2 countries
19
Brief Summary
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2016
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedStudy Start
First participant enrolled
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2017
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedMay 8, 2018
April 1, 2018
12 months
January 28, 2016
March 1, 2018
April 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Week 12
Secondary Outcomes (3)
Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
Week 12 (Follow-up period)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24
Study Arms (1)
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
EXPERIMENTALOral 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.
Interventions
Eligibility Criteria
You may qualify if:
- Genotype 3 HCV
- HCV RNA ≥10000 IU (International Unit)/mL
- Compensated Liver Cirrhosis
- BMI 18-40 kg/m2
- Previously treated for HCV or never treated for HCV
You may not qualify if:
- Infection with HCV other than Genotype 3. Mixed infection of any genotype
- Evidence of decompensated liver disease
- Previous exposure to NS5A inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Keck Medical Center Of USC
Los Angeles, California, 90033, United States
University Of California, San Francisco
San Francisco, California, 94143, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Ruth Rothstein Core Center
Chicago, Illinois, 60612, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Methodist Transplant Physicians
Dallas, Texas, 75203, United States
The Texas Liver Institute
San Antonio, Texas, 78215, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Bon Secours St. Mary's Hospital of Richmond, Inc
Richmond, Virginia, 23226, United States
Local Institution
Calgary, Alberta, T2N 4Z6, Canada
Local Institution
Edmonton, Alberta, T6G 2P4, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local Institution
Toronto, Ontario, M5G 2C4, Canada
Local Institution
Montreal, Quebec, H3T 1E2, Canada
Local Institution
Regina, Saskatchewan, S4O 0W5, Canada
Related Publications (1)
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.
PMID: 30382942DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 4, 2016
Study Start
March 15, 2016
Primary Completion
March 2, 2017
Study Completion
May 26, 2017
Last Updated
May 8, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-04