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Completed

NCT Number: NCT01741545

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pegylated-Interferon-lambda

Biological

Other names: pegIFNλ, BMS-914143

Ribavirin

Drug

Daclatasvir

Drug

Other names: BMS-790052

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants With Rapid Virologic Response (RVR)

    Time frame: Treatment Week 4

    RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.

  2. Percentage of Participants With Complete Early Virologic Response (cEVR)

    Time frame: Treatment Week 12

    cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.

  3. Percentage of Participants With End of the Treatment Response (EOTR)

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

    EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.

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

    Time frame: Follow-up Week 24

    SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

  5. Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

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

    Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.

  6. Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

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

    Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.

  7. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death

    Time frame: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)

    AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.

  8. Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

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

    Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

Acronym: MAGNITUDE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2012
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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