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Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia (MAGNITUDE)

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ClinicalTrials.gov Identifier: NCT01741545
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : June 24, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Biological: Pegylated-Interferon-lambda Drug: Ribavirin Drug: Daclatasvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 31, 2013
Actual Primary Completion Date : January 31, 2015
Actual Study Completion Date : January 31, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)

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
Other Names:
  • pegIFNλ
  • BMS-914143

Drug: Ribavirin
Drug: Daclatasvir
Other Name: BMS-790052

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

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
Other Names:
  • pegIFNλ
  • BMS-914143

Drug: Ribavirin
Drug: Daclatasvir
Other Name: BMS-790052




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01741545


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01741545     History of Changes
Other Study ID Numbers: AI452-030
2012-003463-22 ( EudraCT Number )
First Posted: December 5, 2012    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: August 20, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action