Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01012895 |
Recruitment Status :
Completed
First Posted : November 13, 2009
Last Update Posted : October 9, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Drug: BMS-790052 Drug: BMS-650032 Drug: Pegylated-interferon alfa-2a Drug: Ribavirin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 215 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment [ Time Frame: 12 weeks post treatment ]
- 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 ]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 ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012895
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01012895 |
Other Study ID Numbers: |
AI447-011 2010-024637-23 ( EudraCT Number ) |
First Posted: | November 13, 2009 Key Record Dates |
Last Update Posted: | October 9, 2015 |
Last Verified: | September 2015 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons |
Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Asunaprevir Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Protease Inhibitors Enzyme Inhibitors |