Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)
11 septembre 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
512
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Essen, Allemagne, 45122
- Local Institution
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Frankfurt, Allemagne, 60590
- Local Institution
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Hamburg, Allemagne, 20099
- Local Institution
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Hannover, Allemagne, 30625
- Local Institution
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Buenos Aires
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Ciudad De Buenos Aires, Buenos Aires, Argentine, C1121ABE
- Local Institution
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Ciudad De Buenos Aires, Buenos Aires, Argentine, C1181ACH
- Local Institution
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Santa Fe
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Prov De Santa Fe, Santa Fe, Argentine, 2000
- Local Institution
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New South Wales
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Randwick, New South Wales, Australie, 2031
- Local Institution
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Victoria
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Clayton, Victoria, Australie, 3168
- Local Institution
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Heidelberg, Victoria, Australie, 3084
- Local Institution
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Prahan, Victoria, Australie, 3004
- Local Institution
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Western Australia
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Fremantle, Western Australia, Australie, 6160
- Local Institution
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Perth, Western Australia, Australie, 6001
- Local Institution
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Local Institution
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- Local Institution
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Victoria, British Columbia, Canada, V8V 3P9
- Local Institution
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Local Institution
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Toronto, Ontario, Canada, M5T 2S8
- Local Institution
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Aarhus, Danemark, 8200
- Local Institution
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Hvidovre, Danemark, 2650
- Local Institution
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Odense, Danemark, 5000
- Local Institution
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Clichy Cedex, France, 92118
- Local Institution
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Creteil Cedex, France, 94010
- Local Institution
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Lyon Cedex 04, France, 69317
- Local Institution
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Nice Cedex 03, France, 06202
- Local Institution
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Paris Cedex, France, 75013
- Local Institution
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Paris Cedex 14, France, 75679
- Local Institution
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Vandoeuvre Les Nancy, France, 54511
- Local Institution
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Cisanello (pisa), Italie, 56124
- Local Institution
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Pavia, Italie, 27100
- Local Institution
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Jalisco
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Guadalajara, Jalisco, Mexique, 44160
- Local Institution
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Morelos
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Cuernavaca, Morelos, Mexique, 62170
- Local Institution
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexique, 64710
- Local Institution
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Ponce, Porto Rico, 00780
- Instituto De Investigacion Cientifica Del Sur
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San Juan, Porto Rico, 00927
- Local Institution
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Gothenburg, Suède, SE-416 85
- Local Institution
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Stockholm, Suède, 14186
- Local Institution
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Alabama
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Montgomery, Alabama, États-Unis, 36116
- Alabama Liver & Digestive Specialists (Alds)
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California
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La Jolla, California, États-Unis, 92037
- Scripps Clinic
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Los Angeles, California, États-Unis, 90048
- CLI
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San Diego, California, États-Unis, 92114
- Desta Digestive Disease Medical Center
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San Francisco, California, États-Unis, 94115
- California Pacific Medical Center
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San Francisco, California, États-Unis, 94110
- University of California at San Francisco
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San Francisco, California, États-Unis, 94118
- Kaiser Permanente Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Transplant Center And Hepatology Clinic, B-154
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Connecticut
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New Haven, Connecticut, États-Unis, 06520
- Yale University School Of Medicine
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Florida
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Gainesville, Florida, États-Unis, 32610-0277
- University Of Florida Hepatology
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South Miami, Florida, États-Unis, 33143
- Miami Research Associates
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, États-Unis, 21202
- Mercy Medical Center
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Baltimore, Maryland, États-Unis, 21229
- Digestive Disease Associates, P.A.
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Lutherville, Maryland, États-Unis, 21093
- Johns Hopkins Medical Institutions
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Massachusetts
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Springfield, Massachusetts, États-Unis, 01105
- The Research Institute
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Missouri
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St. Louis, Missouri, États-Unis, 63104
- Saint Louis University
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New York
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Albany, New York, États-Unis, 12208
- Samuel S. Stratton Vamc
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Bronx, New York, États-Unis, 10468
- James J Peters VAMC
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Great Neck, New York, États-Unis, 11201
- James Sungsik Park, M.D. C.N.S.C.
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Monticello, New York, États-Unis, 12701
- Upper Delaware Valley Infectious Diseases, Pc
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Rochester, New York, États-Unis, 14642
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7584
- University of North Carolina, Chapel Hill
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Statesville, North Carolina, États-Unis, 28677
- Carolinas Center For Liver Disease
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74135
- Healthcare Research Consultants
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, États-Unis, 02905
- University Gastroenterology
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Tennessee
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Nashville, Tennessee, États-Unis, 37205
- Nashville Medical Research Institute
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Texas
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Arlington, Texas, États-Unis, 76012
- North Texas Research Institute
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Houston, Texas, États-Unis, 77030
- Liver Associates of Texas
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Houston, Texas, États-Unis, 77030
- St. Luke'S Episcopal Hospital - Baylor College Of Medicine
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San Antonio, Texas, États-Unis, 78215
- Alamo Medical Research
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Virginia
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Fairfax, Virginia, États-Unis, 22031
- Metropolitan Research
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Wisconsin
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Madison, Wisconsin, États-Unis, 53715
- Dean Clinic
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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
Autres noms:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Autres noms:
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Expérimental: Arm 2: 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
Autres noms:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Autres noms:
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Expérimental: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial 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
Autres noms:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Autres noms:
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Expérimental: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial 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
Autres noms:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Autres noms:
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Expérimental: 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
Autres noms:
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Autres noms:
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Rapid Virologic Response (RVR)
Délai: Week 4
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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)
Délai: 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)
Délai: Follow-up Week 12
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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
Délai: 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
Délai: Baseline to follow-up Week 48
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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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2010
Achèvement primaire (Réel)
1 juin 2012
Achèvement de l'étude (Réel)
1 décembre 2012
Dates d'inscription aux études
Première soumission
16 juillet 2010
Première soumission répondant aux critères de contrôle qualité
26 juillet 2010
Première publication (Estimation)
28 juillet 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
12 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2015
Dernière vérification
1 septembre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Hépatite
- Hépatite C
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites
- Ribavirine
- Peginterféron alfa-2a
Autres numéros d'identification d'étude
- AI444-011
- 2010-019378-34 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .