Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01012895
First received: November 12, 2009
Last updated: March 28, 2013
Last verified: February 2012
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Purpose
The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: BMS-790052 Drug: BMS-650032 Drug: Pegylated-interferon alfa-2a Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: Yes ]Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)
- Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16 ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | February 2014 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1: Sentinel A
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
|
|
Experimental: Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks Other Name: Copegus
|
|
Experimental: Arm 3: Expansion A1
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
|
|
Experimental: Arm 4: Expansion A2
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
|
|
Experimental: Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks Other Name: Copegus
|
|
Experimental: Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks Other Name: Copegus
|
|
Experimental: Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
|
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: Ribavirin
Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks Other Name: Copegus
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects ages 18 to 70 years
- HCV-Infected Genotype 1 Null responders to current standard of care
- Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.
Exclusion Criteria:
- Evidence of a medical condition associate with chronic liver disease other than HCV
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
- History of Cancer within 5 years of enrollment
- History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
- History of clinically significant cardiac disease
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Documented cirrhosis within 12 months prior to dosing
- Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
- Pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012895
Locations
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Southern California Liver Centers | |
| Coronado, California, United States, 92118 | |
| San Jose Gastroenterology | |
| San Jose, California, United States, 95128 | |
| United States, Colorado | |
| University Of Colorado Denver & Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Maryland | |
| Mercy Medical Center | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Michigan | |
| University Of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, North Carolina | |
| Carolinas Center For Liver Disease | |
| Statesville, North Carolina, United States, 28677 | |
| United States, Texas | |
| Texas Clinical Research Institute, Llc | |
| Arlington, Texas, United States, 76012 | |
| Alamo Medical Research | |
| San Antonio, Texas, United States, 78215 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| France | |
| Local Institution | |
| Clichy Cedex, France, 92118 | |
| Local Institution | |
| Creteil Cedex, France, 94010 | |
| Local Institution | |
| Marseille Cedex 08, France, 13285 | |
| Local Institution | |
| Paris Cedex 12, France, 75571 | |
| Local Institution | |
| Paris Cedex 13, France, 75651 | |
| Local Institution | |
| Paris Cedex 14, France, 75679 | |
| Local Institution | |
| Pessac, France, 33604 | |
| Puerto Rico | |
| Local Institution | |
| San Juan, Puerto Rico, 00927 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01012895 History of Changes |
| Other Study ID Numbers: | AI447-011, 2010-024637-23 |
| Study First Received: | November 12, 2009 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board European Union: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a |
Interferons Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013