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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01741545

AI452-030

2012-003463-22 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Biological: Pegylated-Interferon-lambda

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

Experimental group

Description:

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

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Biological: Pegylated-Interferon-lambda