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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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-790052
BMS-650032
BMS-650032
BMS-650032
Pegylated-interferon alfa-2a
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Research Institute
  • Southern California Liver Centers
  • San Jose Gastroenterology
  • University Of Colorado Denver & Hospital
  • Mercy Medical Center
  • University Of Michigan Health System
  • Carolinas Center For Liver Disease
  • Texas Clinical Research Institute, Llc
  • Alamo Medical Research
  • Metropolitan Research
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: Sentinel A

Arm 2: Sentinel B

Arm 3: Expansion A1

Arm 4: Expansion A2

Arm 5: Expansion B1

Arm 6: Expansion B2

Arm 7: Expansion B3

Arm Description

BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily

BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin

BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily

BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily

BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin

BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin

BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin

Outcomes

Primary Outcome Measures

Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment

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
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.
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.
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.
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.

Full Information

First Posted
November 12, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01012895
Brief Title
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Sentinel A
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
Arm Title
Arm 2: Sentinel B
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Arm Title
Arm 3: Expansion A1
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
Arm Title
Arm 4: Expansion A2
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
Arm Title
Arm 5: Expansion B1
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Arm Title
Arm 6: Expansion B2
Arm Type
Experimental
Arm Description
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
Arm Title
Arm 7: Expansion B3
Arm Type
Experimental
Arm Description
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Intervention Description
Tablets, Oral, 60 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Tablets, Oral, 600 mg, twice daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Tablets, Oral, 200mg, twice daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Tablets, Oral, 200 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated-interferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous Injection, 180 µg, once weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
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
Primary Outcome Measure Information:
Title
Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
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
Description
Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)
Time Frame
12 weeks post-treatment
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Southern California Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
San Jose Gastroenterology
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
University Of Colorado Denver & Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University Of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Carolinas Center For Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Texas Clinical Research Institute, Llc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Marseille Cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
26683763
Citation
Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
Results Reference
derived
PubMed Identifier
23504694
Citation
McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.
Results Reference
derived
PubMed Identifier
22256805
Citation
Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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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