Hepatitis C Virus Clinical Trial
— HEPCATOfficial title:
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.
Status | Completed |
Enrollment | 512 |
Est. completion date | December 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Local Institution | Ciudad De Buenos Aires | Buenos Aires |
Argentina | Local Institution | Ciudad De Buenos Aires | Buenos Aires |
Argentina | Local Institution | Prov De Santa Fe | Santa Fe |
Australia | Local Institution | Clayton | Victoria |
Australia | Local Institution | Fremantle | Western Australia |
Australia | Local Institution | Heidelberg | Victoria |
Australia | Local Institution | Perth | Western Australia |
Australia | Local Institution | Prahan | Victoria |
Australia | Local Institution | Randwick | New South Wales |
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 | |
France | Local Institution | Clichy Cedex | |
France | Local Institution | Creteil Cedex | |
France | Local Institution | Lyon Cedex 04 | |
France | Local Institution | Nice Cedex 03 | |
France | Local Institution | Paris Cedex | |
France | Local Institution | Paris Cedex 14 | |
France | Local Institution | Vandoeuvre Les Nancy | |
Germany | Local Institution | Essen | |
Germany | Local Institution | Frankfurt | |
Germany | Local Institution | Hamburg | |
Germany | Local Institution | Hannover | |
Italy | Local Institution | Cisanello (pisa) | |
Italy | Local Institution | Pavia | |
Mexico | Local Institution | Cuernavaca | Morelos |
Mexico | Local Institution | Guadalajara | Jalisco |
Mexico | Local Institution | Monterrey | Nuevo Leon |
Puerto Rico | Instituto De Investigacion Cientifica Del Sur | Ponce | |
Puerto Rico | Local Institution | San Juan | |
Sweden | Local Institution | Gothenburg | |
Sweden | Local Institution | Stockholm | |
United States | Samuel S. Stratton Vamc | Albany | New York |
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, Chapel Hill | 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 | Liver Associates Of Texas | Houston | Texas |
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 Medical Institutions | Lutherville | Maryland |
United States | Dean Clinic | Madison | Wisconsin |
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 | University Of Rochester Medical Center | Rochester | New York |
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 At San Francisco | San Francisco | California |
United States | Miami Research Associates | South Miami | Florida |
United States | The Research Institute | Springfield | Massachusetts |
United States | Saint Louis University | St. Louis | Missouri |
United States | Carolinas Center For Liver Disease | Statesville | North Carolina |
United States | Healthcare Research Consultants | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Argentina, Australia, Canada, Denmark, France, Germany, Italy, Mexico, Puerto Rico, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 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. | Week 4, Week 12 | No |
Primary | Percentage of Participants With 24-week Sustained Virologic Response (SVR24) | SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA Follow-up Week 24 |
No |
|
Primary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment | 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. | From first dose to last dose plus 7 days, up to 49 weeks | Yes |
Primary | Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period | 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. | From day 8 post last dose of treatment up-to Week 72 | Yes |
Secondary | Percentage of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Week 4 |
No |
|
Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Week 12 |
No |
|
Secondary | Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) | SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Follow-up Week 12 |
No |
|
Secondary | Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures | 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. | Baseline to follow-up Week 48 | No |
Secondary | Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures | 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. | Baseline to follow-up Week 48 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02907996 -
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
|
||
Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
Not yet recruiting |
NCT02893046 -
HCV Care Pathway in Ile-de-France
|
N/A | |
Completed |
NCT01428063 -
Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials
|
Phase 2 | |
Completed |
NCT01396005 -
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
|
Phase 1 | |
Completed |
NCT01195181 -
Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
|
Phase 4 | |
Completed |
NCT00219999 -
Hepatitis C Virus and the Humoral Immune System
|
N/A | |
Completed |
NCT02243293 -
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
|
Phase 2/Phase 3 | |
Completed |
NCT02265237 -
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)
|
Phase 3 | |
Not yet recruiting |
NCT06104046 -
Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
|
||
Completed |
NCT02604017 -
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
|
Phase 3 | |
Withdrawn |
NCT00947245 -
Japanese Bridging Study Conducted in the United States
|
Phase 1 | |
Completed |
NCT01713283 -
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
Completed |
NCT01458535 -
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
|
Phase 2 | |
Completed |
NCT01479881 -
A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus
|
Phase 1 | |
Completed |
NCT01193361 -
Ph IIA Study (SOC +/- NS5B)
|
Phase 2 | |
Completed |
NCT01241773 -
TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir
|
Phase 1 | |
Completed |
NCT01006031 -
Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4
|
Phase 2/Phase 3 | |
Completed |
NCT00819026 -
Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors
|
N/A | |
Completed |
NCT00382798 -
Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
|
Phase 1/Phase 2 |