Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
1 other identifier
interventional
350
2 countries
18
Brief Summary
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
18 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
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedOctober 23, 2015
September 1, 2015
1.6 years
May 23, 2011
August 21, 2015
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12
Secondary Outcomes (6)
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
- +1 more secondary outcomes
Study Arms (10)
Treatment A: PSI-7977 + Daclatasvir
EXPERIMENTALGenotype 1a or 1b
Treatment B: PSI-7977 + Daclatasvir
EXPERIMENTALGenotype 2 or 3
Treatment C: PSI-7977 + Daclatasvir
EXPERIMENTALGenotype 1a or 1b
Treatment D: PSI-7977 + Daclatasvir
EXPERIMENTALGenotype 2 or 3
Treatment E: PSI-7977 + Daclatasvir + Ribavirin
EXPERIMENTALGenotype 1a or 1b
Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
EXPERIMENTALGenotype 2 or 3
Treatment G: PSI-7977 + Daclatasvir
EXPERIMENTALHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Treatment H: PSI-7977 + BMS-790052 + Ribavirin
EXPERIMENTALHepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b
Treatment I: PSI-7977 + Daclatasvir
EXPERIMENTALPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Treatment J: PSI-7977 + Daclatasvir + Ribavirin
EXPERIMENTALPatients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
Interventions
Tablets, oral, 400 mg, once daily
Tablets, oral, 60 mg, once daily
Tablets, oral, 200 mg
Eligibility Criteria
You may qualify if:
- Men and women, ages 18 to 70 years.
- Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
- Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.
You may not qualify if:
- Evidence of a medical condition associate with chronic liver disease other than HCV.
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
- History of hemophilia.
- History of torsade de pointes.
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
- History of gastrointestinal disease or surgical procedure (except cholecystectomy).
- History of clinically significant cardiac disease.
- Blood transfusion within 4 weeks prior to study drug administration.
- Poor venous access.
- Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pharmassetcollaborator
Study Sites (18)
Southern California Liver Centers
Coronado, California, 92118, United States
Research And Education, Inc.
San Diego, California, 92105, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045, United States
University Of Florida Hepatology
Gainesville, Florida, 32610, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
University Of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Bronx Va Medical Center 3c Sub-J
The Bronx, New York, 10468, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Annandale, Virginia, 22003, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
San Juan, 00927, Puerto Rico
Related Publications (1)
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.
PMID: 24428467DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 25, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
October 1, 2013
Last Updated
October 23, 2015
Results First Posted
October 23, 2015
Record last verified: 2015-09