Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
2 other identifiers
interventional
74
2 countries
14
Brief Summary
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
14 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
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedOctober 23, 2015
September 1, 2015
5 months
April 2, 2009
August 6, 2015
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
A Weeks 4 and 12
Secondary Outcomes (3)
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
At Week 4
Percentage of Participants With Early Virologic Response (EVR) at Week 12
At Week 12
Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
At Week 12
Other Outcomes (3)
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
From Day 31 up to Week 24 of post treatment follow-up
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
From screening up to Week 12 (treatment period)
Study Arms (4)
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
EXPERIMENTALActive Comparator
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
EXPERIMENTALActive Comparator
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
EXPERIMENTALActive Comparator
Placebo, Peginterferon alpha-2a, ribavirin (D)
ACTIVE COMPARATORInterventions
Tablets, oral, 3 mg, Daily, 48 weeks
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Eligibility Criteria
You may qualify if:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
- Treatment naive
You may not qualify if:
- Women of child-bearing potential
- Cirrhosis
- Coinfection with HIV or hepatitis B virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Llc Dba The Research Institute
Springfield, Massachusetts, 01107, United States
Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
North Texas Research Institute
Arlington, Texas, 76012, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Local Institution
Créteil, 94010, France
Local Institution
Paris, 75679, France
Local Institution
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.
PMID: 22714001DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BristolMyers Squibb Study Director
- Organization
- Bristol-Myers Squibb International Corporation
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2009
Study Completion
January 1, 2011
Last Updated
October 23, 2015
Results First Posted
October 23, 2015
Record last verified: 2015-09