Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)
11 de septiembre de 2015 actualizado por: Bristol-Myers Squibb
A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
512
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Essen, Alemania, 45122
- Local Institution
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Frankfurt, Alemania, 60590
- Local Institution
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Hamburg, Alemania, 20099
- Local Institution
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Hannover, Alemania, 30625
- Local Institution
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Buenos Aires
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Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
- Local Institution
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Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
- Local Institution
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Santa Fe
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Prov De Santa Fe, Santa Fe, Argentina, 2000
- Local Institution
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Local Institution
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Victoria
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Clayton, Victoria, Australia, 3168
- Local Institution
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Heidelberg, Victoria, Australia, 3084
- Local Institution
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Prahan, Victoria, Australia, 3004
- Local Institution
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Local Institution
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Perth, Western Australia, Australia, 6001
- Local Institution
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Alberta
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Edmonton, Alberta, Canadá, T6G 2B7
- Local Institution
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British Columbia
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Vancouver, British Columbia, Canadá, V6Z 2K5
- Local Institution
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Victoria, British Columbia, Canadá, V8V 3P9
- Local Institution
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Ontario
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Toronto, Ontario, Canadá, M5G 2N2
- Local Institution
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Toronto, Ontario, Canadá, M5T 2S8
- Local Institution
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Aarhus, Dinamarca, 8200
- Local Institution
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Hvidovre, Dinamarca, 2650
- Local Institution
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Odense, Dinamarca, 5000
- Local Institution
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Alabama
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Montgomery, Alabama, Estados Unidos, 36116
- Alabama Liver & Digestive Specialists (Alds)
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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Los Angeles, California, Estados Unidos, 90048
- CLI
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San Diego, California, Estados Unidos, 92114
- Desta Digestive Disease Medical Center
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San Francisco, California, Estados Unidos, 94115
- California Pacific Medical Center
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San Francisco, California, Estados Unidos, 94110
- University of California at San Francisco
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San Francisco, California, Estados Unidos, 94118
- Kaiser Permanente Medical Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Transplant Center And Hepatology Clinic, B-154
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University School Of Medicine
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Florida
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Gainesville, Florida, Estados Unidos, 32610-0277
- University Of Florida Hepatology
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South Miami, Florida, Estados Unidos, 33143
- Miami Research Associates
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, Estados Unidos, 21202
- Mercy Medical Center
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Baltimore, Maryland, Estados Unidos, 21229
- Digestive Disease Associates, P.A.
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Lutherville, Maryland, Estados Unidos, 21093
- Johns Hopkins Medical Institutions
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01105
- The Research Institute
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Missouri
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St. Louis, Missouri, Estados Unidos, 63104
- Saint Louis University
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New York
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Albany, New York, Estados Unidos, 12208
- Samuel S. Stratton Vamc
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Bronx, New York, Estados Unidos, 10468
- James J Peters VAMC
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Great Neck, New York, Estados Unidos, 11201
- James Sungsik Park, M.D. C.N.S.C.
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Monticello, New York, Estados Unidos, 12701
- Upper Delaware Valley Infectious Diseases, Pc
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7584
- University of North Carolina, Chapel Hill
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Statesville, North Carolina, Estados Unidos, 28677
- Carolinas Center For Liver Disease
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74135
- Healthcare Research Consultants
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- University Gastroenterology
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- Nashville Medical Research Institute
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Texas
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Arlington, Texas, Estados Unidos, 76012
- North Texas Research Institute
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Houston, Texas, Estados Unidos, 77030
- Liver Associates of Texas
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Houston, Texas, Estados Unidos, 77030
- St. Luke'S Episcopal Hospital - Baylor College Of Medicine
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San Antonio, Texas, Estados Unidos, 78215
- Alamo Medical Research
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Metropolitan Research
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53715
- Dean Clinic
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Clichy Cedex, Francia, 92118
- Local Institution
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Creteil Cedex, Francia, 94010
- Local Institution
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Lyon Cedex 04, Francia, 69317
- Local Institution
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Nice Cedex 03, Francia, 06202
- Local Institution
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Paris Cedex, Francia, 75013
- Local Institution
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Paris Cedex 14, Francia, 75679
- Local Institution
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Vandoeuvre Les Nancy, Francia, 54511
- Local Institution
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Cisanello (pisa), Italia, 56124
- Local Institution
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Pavia, Italia, 27100
- Local Institution
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Jalisco
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Guadalajara, Jalisco, México, 44160
- Local Institution
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Morelos
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Cuernavaca, Morelos, México, 62170
- Local Institution
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Nuevo Leon
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Monterrey, Nuevo Leon, México, 64710
- Local Institution
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Ponce, Puerto Rico, 00780
- Instituto De Investigacion Cientifica Del Sur
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San Juan, Puerto Rico, 00927
- Local Institution
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Gothenburg, Suecia, SE-416 85
- Local Institution
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Stockholm, Suecia, 14186
- Local Institution
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
Exclusion Criteria:
- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
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Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Otros nombres:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Otros nombres:
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Experimental: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
|
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Otros nombres:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Otros nombres:
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Experimental: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
|
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Otros nombres:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Otros nombres:
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Experimental: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
|
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Otros nombres:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Otros nombres:
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Experimental: Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
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Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Otros nombres:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Otros nombres:
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Periodo de tiempo: Week 4, Week 12
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eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 4, Week 12
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Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
Periodo de tiempo: Follow-up Week 24
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SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24.
TND was 10 IU/mL.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Follow-up Week 24
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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Periodo de tiempo: From first dose to last dose plus 7 days, up to 49 weeks
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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From first dose to last dose plus 7 days, up to 49 weeks
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Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Periodo de tiempo: From day 8 post last dose of treatment up-to Week 72
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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From day 8 post last dose of treatment up-to Week 72
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Rapid Virologic Response (RVR)
Periodo de tiempo: Week 4
|
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL.
HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 4
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Percentage of Participants With Complete Early Virologic Response (cEVR)
Periodo de tiempo: Week 12
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cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL.
HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12
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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Periodo de tiempo: Follow-up Week 12
|
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Follow-up Week 12
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Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Periodo de tiempo: Baseline to follow-up Week 48
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Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
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Baseline to follow-up Week 48
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Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Periodo de tiempo: Baseline to follow-up Week 48
|
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
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Baseline to follow-up Week 48
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2010
Finalización primaria (Actual)
1 de junio de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2010
Publicado por primera vez (Estimar)
28 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2015
Última verificación
1 de septiembre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Hepatitis
- Hepatitis C
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Antimetabolitos
- Ribavirina
- Peginterferón alfa-2a
Otros números de identificación del estudio
- AI444-011
- 2010-019378-34 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .