Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

Hepatitis C Virus Clinical Trial

— HEPCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125189
• Other study ID #: AI444-010
• Secondary ID: 2010-018295-24
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2010
• Last updated: September 23, 2015
• Start date: July 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilCanada: Health CanadaCanada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products DirectorateDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research EthicsEgypt: National Ethic CommitteeEgypt: Ministry of Health, Drug Policy and Planning CenterFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyMexico: Federal Commission for Sanitary Risks ProtectionSweden: Medical Products AgencySweden: The National Board of Health and WelfareSweden: The Swedish Data Inspection BoardSweden: Central Ethics BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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, pegIFNa, 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Daclatasvir
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
• Daclatasvir
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
• Placebo
Tablets, oral, 0 mg, once daily, 24 weeks
• peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
• ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown
Australia	Local Institution	Clayton Vic	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Westmead Nsw	New South Wales
Australia	Local Institution	Woolloongabba	Queensland
Canada	Local Institution	Edmonton	Alberta
Canada	Local institution	Toronto	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
Denmark	Local Institution	Aarhus
Denmark	Local Institution	Hvidovre
Denmark	Local Institution	Odense
Egypt	Local Institution	Cairo
Egypt	Local Institution	Shebin Elkom	Menoufiya
France	Local Institution	Creteil
France	Local Institution	Marseille Cedex 08
France	Local Institution	Montpellier Cedex 5
France	Local Instituition	Paris Cedex 12
France	Local Institution	Paris Cedex 14
Germany	Local Institution	Duesseldorf
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Hamburg
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Pavia
Mexico	Local Institution	Guadalajara	Jalisco
Puerto Rico	Local Institution	San Juan
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Stockholm
United States	North Texas Research Institute	Arlington	Texas
United States	Transplant Center And Hepatology Clinic, B-154	Aurora	Colorado
United States	Digestive Disease Associates, P.A.	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	James J Peters Vamc	Bronx	New York
United States	University Of North Carolina At Chapel Hill School Of Med	Chapel Hill	North Carolina
United States	Metropolitan Research	Fairfax	Virginia
United States	University Of Florida Hepatology	Gainesville	Florida
United States	James Sungsik Park, M.D. C.N.S.C.	Great Neck	New York
United States	St. Luke'S Episcopal Hospital - Baylor College Of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Scripps Clinic	La Jolla	California
United States	Cli	Los Angeles	California
United States	Johns Hopkins University	Lutherville	Maryland
United States	Dean Clinic	Madison	Wisconsin
United States	University Of Miami	Miami	Florida
United States	Alabama Liver & Digestive Specialists (Alds)	Montgomery	Alabama
United States	Upper Delaware Valley Infectious Diseases, Pc	Monticello	New York
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Alamo Medical Research	San Antonio	Texas
United States	Desta Digestive Disease Medical Center	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Kaiser Permanente Medical Center	San Francisco	California
United States	University Of California, San Francisco/Sf General Hospital	San Francisco	California
United States	Miami Research Associates	South Miami	Florida
United States	Claudia T. Martorell, Md, Llc	Springfield	Massachusetts
United States	Carolinas Center For Liver Disease	Statesville	North Carolina
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Egypt,  France,  Germany,  Italy,  Mexico,  Puerto Rico,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)	eRVR was defined as HCV RNA	Weeks 4 and 12	No
Primary	Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)	SVR24 was defined as HCV	Follow-up Week 24	No
Primary	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	Yes
Secondary	Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)	RVR was defined as undetectable RNA (HCV RNA	Week 4	No
Secondary	Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)	cEVR was defined as undetectable RNA (HCV RNA	Week 12	No
Secondary	Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)	SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and	Follow-up Week 12	No
Secondary	Percentage of Resistant Variants Associated With Virologic Failure	Virologic failure was defined as: Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment; Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment; HCV RNA < LLOQ, TD or = LLOQ at Week 12 and = LLOQ at Week 24; HCV RNA =LLOQ or Relapse, defined as HCV RNA =LLOQ or The LLOQ was 25 IU/mL, and	Follow-up Week 48	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
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