Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
HEPCAT
A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
2 other identifiers
interventional
558
11 countries
64
Brief Summary
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
64 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 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedOctober 23, 2015
September 1, 2015
1.8 years
May 17, 2010
August 13, 2015
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as HCV RNA \<lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Weeks 4 and 12
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
SVR24 was defined as HCV \<lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From start of study treatment (day 1) up to follow-up Week 48
Secondary Outcomes (4)
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
Week 4
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
Week 12
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
Follow-up Week 12
Percentage of Resistant Variants Associated With Virologic Failure
Follow-up Week 48
Study Arms (3)
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)
EXPERIMENTALDaclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)
EXPERIMENTALPlacebo plus peg-interferon alfa-2a and ribavirin
PLACEBO COMPARATORInterventions
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
Tablets, oral, 0 mg, once daily, 24 weeks
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Eligibility Criteria
You may qualify if:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
- HCV RNA viral load of ≥100,000 IU/mL
- No previous exposure to interferon, pegIFNα, or RBV
- Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
- Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
- Body mass index of 18 to 35 kg/m\^2
You may not qualify if:
- Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
- Evidence of a medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116, United States
Scripps Clinic
La Jolla, California, 92037, United States
Cli
Los Angeles, California, 90048, United States
Desta Digestive Disease Medical Center
San Diego, California, 92114, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, 94110, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, 80045, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
University Of Florida Hepatology
Gainesville, Florida, 32610, United States
University Of Miami
Miami, Florida, 33136, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Claudia T. Martorell, Md, Llc
Springfield, Massachusetts, 01105, United States
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, 11201, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, 12701, United States
James J Peters Vamc
The Bronx, New York, 10468, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, 27599, 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
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
North Texas Research Institute
Arlington, Texas, 76012, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
Darlinghurst, New South Wales, 2010, Australia
Local Institution
Westmead Nsw, New South Wales, 2145, Australia
Local Institution
Woolloongabba, Queensland, 4102, Australia
Local Institution
Adelaide, South Australia, 5000, Australia
Local Institution
Clayton Vic, Victoria, 3168, Australia
Local Institution
Camperdown, NSW 2050, Australia
Local Institution
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local institution
Toronto, Ontario, M5G 2N2, Canada
Local Institution
Toronto, Ontario, M5T 2S8, Canada
Local Institution
Aarhus, 8200, Denmark
Local Institution
Hvidovre, 2650, Denmark
Local Institution
Odense, 5000, Denmark
Local Institution
Shebin Elkom, Monufia Governorate, 35111, Egypt
Local Institution
Cairo, 11559, Egypt
Local Institution
Créteil, 94000, France
Local Institution
Marseille, 13285, France
Local Institution
Montpellier, 34295, France
Local Instituition
Paris, 75571, France
Local Institution
Paris, 75679, France
Local Institution
Düsseldorf, 40237, Germany
Local Institution
Essen, 45122, Germany
Local Institution
Frankfurt, 60590, Germany
Local Institution
Hamburg, 20099, Germany
Local Institution
Cisanello (pisa), 56124, Italy
Local Institution
Pavia, 27100, Italy
Local Institution
Guadalajara, Jalisco, 44340, Mexico
Local Institution
San Juan, 00927, Puerto Rico
Local Institution
Gothenburg, SE-416 85, Sweden
Local Institution
Stockholm, 141 86, Sweden
Related Publications (1)
Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.
PMID: 25080450DERIVED
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
- 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
May 17, 2010
First Posted
May 18, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2012
Study Completion
August 1, 2012
Last Updated
October 23, 2015
Results First Posted
October 23, 2015
Record last verified: 2015-09