Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

NCT01030432 | Completed Phase 2

• 2 other identifiers: AI447-0162009-013652-69
• Study Type: interventional
• Target: 285
• Locations: 8 countries
• Sites: 40

Brief Summary

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (4)

• Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs

  12 weeks after first dose

• Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

  Week 4

• Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

  Week 12

• Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA

  at follow-up Week 24

Secondary Outcomes (6)

• Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4

  Week 4

• Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)

  at Week 12 (Stage 2 only)

• Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)

  Week 12 (Stage 1 only)

• Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12

  follow-up Week 12

• Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)

  follow-up Week 24 (Stage 1 only)

Study Arms (4)

Phase 2a: Arm 1

EXPERIMENTAL

Drug: BMS-650032; Drug: Peginterferon Alfa-2a; Drug: Ribavirin

Phase 2a: Arm 2

PLACEBO COMPARATOR

Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin

Phase 2b: Arm 1

EXPERIMENTAL

Drug: BMS-650032; Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin

Phase 2b: Arm 2

PLACEBO COMPARATOR

Drug: Placebo; Drug: Peginterferon Alfa-2a; Drug: Ribavirin

Interventions

BMS-650032 DRUG

Tablets, Oral, 200 mg, Twice Daily, 48 weeks

Phase 2a: Arm 1

Placebo DRUG

Tablets, Oral, 0 mg, twice daily, 48 weeks

Also known as: Pegasys

Phase 2a: Arm 2

Peginterferon Alfa-2a DRUG

Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks

Also known as: Pegasys

Phase 2a: Arm 1; Phase 2a: Arm 2; Phase 2b: Arm 2

Ribavirin DRUG

Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks

Also known as: Copegus

Phase 2a: Arm 1; Phase 2a: Arm 2; Phase 2b: Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
• Subjects chronically infected with HCV genotype 4 (Phase 2b only)
• HCV RNA viral load of ≥ 10\*5\* IU/mL at screening
• BMI of 18 - 35 kg/m² at screening

You may not qualify if:

• Cirrhosis (Phase 2a only)
• Decompensated cirrhosis (Phase 2b)
• Co-infection with HBV or HIV
• Hepatocellular carcinoma
• Prior treatment with anti-HCV drugs

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (40)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, 36116, United States

Location

Florida Hospital Transplant Center

Orlando, Florida, 32804, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Umass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

James J Peters Vamc

The Bronx, New York, 10468, United States

Location

University Of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135-2920, United States

Location

Oregon Health Science Univ

Portland, Oregon, 97239, United States

Location

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Dean Clinic

Madison, Wisconsin, 53715, United States

Location

Local Institution

Buenos Aires, Buenos Aires, C1181, Argentina

Location

Local Institution

Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina

Location

Local Institution

Prov. Buenos Aires, Buenos Aires, 1629, Argentina

Location

Local Institution

Prov de Santa Fe, Santa Fe Province, 2000, Argentina

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Marseille, 13285, France

Location

Local Instituition

Montpellier, 34295, France

Location

Local Institution

Paris, 75651, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution

Frankfurt, 60590, Germany

Location

Local Institution

Heidelberg, 69120, Germany

Location

Local Institution

Mainz, 55131, Germany

Location

Local Institution

Würzburg, 97080, Germany

Location

Local Institution

Dublin, Dublin, DUBLIN 7, Ireland

Location

Local Institution

Torino, 10126, Italy

Location

Local Institution

Alicante, 03010, Spain

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Madrid, 28222, Spain

Location

Local Institution

Málaga, 29010, Spain

Location

Local Institution

Valencia, 46010, Spain

Location

Local Institution

London, Greater London, E1 2AT, United Kingdom

Location

Local Institution

London, Greater London, SE5 9RS, United Kingdom

Location

Local Institution

London, Greater London, W2 1NY, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, M8 5RB, United Kingdom

Location

Local Institution

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Related Publications (1)

• Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.

  PMID: 25038486 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

asunaprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 9, 2015

Record last verified: 2015-09

Locations

IE (1); US (14); IT (1); AR (4); GB (5); FR (6); DE (4); ES (5)