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Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

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ClinicalTrials.gov Identifier: NCT01012895
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: BMS-790052 Drug: BMS-650032 Drug: Pegylated-interferon alfa-2a Drug: Ribavirin Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment [ Time Frame: 12 weeks post treatment ]

Secondary Outcome Measures :
  1. 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)

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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Additional Information:
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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 ( EudraCT Number )
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs