Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

NCT01741545 | Completed Phase 3 Results

• 2 other identifiers: AI452-0302012-003463-22
• Study Type: interventional
• Target: 71
• Locations: 8 countries
• Sites: 32

Brief Summary

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

  SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

  Follow-up Week 12

Secondary Outcomes (8)

• Percentage of Participants With Rapid Virologic Response (RVR)

  Treatment Week 4

• Percentage of Participants With Complete Early Virologic Response (cEVR)

  Treatment Week 12

• Percentage of Participants With End of the Treatment Response (EOTR)

  End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)

• Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

  Follow-up Week 24

• Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

  After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

Study Arms (2)

Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)

EXPERIMENTAL

Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks

Biological: Pegylated-Interferon-lambda; Drug: Ribavirin; Drug: Daclatasvir

Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

EXPERIMENTAL

Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks

Biological: Pegylated-Interferon-lambda; Drug: Ribavirin; Drug: Daclatasvir

Interventions

Pegylated-Interferon-lambda BIOLOGICAL

Also known as: pegIFNλ, BMS-914143

Cohort A: Genotype-2,-3 (Lambda/RBV/DCV); Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

Ribavirin DRUG

Cohort A: Genotype-2,-3 (Lambda/RBV/DCV); Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

Daclatasvir DRUG

Also known as: BMS-790052

Cohort A: Genotype-2,-3 (Lambda/RBV/DCV); Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

Eligibility Criteria

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

You may qualify if:

• Severe hemophilia (defined as \< 1% factor activity level)
• Infection with the hepatitis C virus (HCV) with underlying hemophilia
• Males 18 years of age and above
• Have not been previously treated with an interferon

You may not qualify if:

• Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Chronic liver disease caused by any disease other than chronic HCV infection
• Presence of Bethesda inhibitor
• Current evidence of or history of portal hypertension

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (32)

Stanford Boswell Clinic

Palo Alto, California, 94304, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Centers Of America

Murray, Utah, 84123, United States

Location

Local Institution

Camperdown, New South Wales, 2050, Australia

Location

Local Institution

Herston, Queensland, 4029, Australia

Location

Local Institution

Adelaide, South Australia, 5000, Australia

Location

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Local Institution

Herston, 4029, Australia

Location

Local Institution

Grenoble, 38043, France

Location

Local Institution

Lyon, 69317, France

Location

Local Institution

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

Florence, 50134, Italy

Location

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Milan, 20122, Italy

Location

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Roma, 00185, Italy

Location

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Torino, 10126, Italy

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Nijmegen, 6525 GA, Netherlands

Location

Local Institution

Rotterdam, 3015 CE, Netherlands

Location

Local Institution

Utrecht, 3508 GA, Netherlands

Location

Local Institution

Bucharest, 50524, Romania

Location

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Constanța, 900635, Romania

Location

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Iași, 700116, Romania

Location

Local Institution

Iași, 700506, Romania

Location

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Moscow, 107996, Russia

Location

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Saint Petersburg, 191186, Russia

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28046, Spain

Location

Local Institution

Seville, 41013, Spain

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon lambda-1a; Ribavirin; daclatasvir

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

Results Point of Contact

• Title: Bristol Myers Squibb Study Director
• Organization: Bristol Myers Squibb

clinical.trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: March 31, 2013
• Primary Completion: January 31, 2015
• Study Completion: January 31, 2015
• Last Updated: August 11, 2020
• Results First Posted: June 24, 2019

Record last verified: 2020-08

Locations

ES (3); NL (4); RU (2); IT (4); AU (5); FR (6); US (4); RO (4)