A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-30

Study Completion Date

2029-12-13

Brief Summary

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A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors.

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Detailed Description

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The objective of this study is to assess the safety of this drug under actual usage conditions in patients with congenital hemophilia who do not have inhibitors.

The observation period will be up to three years. However, for cases in which administration of the drug is discontinued, information will be collected up to the point of discontinuation.

Conditions

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Hemophilia A or B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Marstacimab

hemophilia patients without inhibitor

Marstacimab

Intervention Type DRUG

For patients aged 12 years or older and weighing at least 35 kg, marstacimab is administered subcutaneously at a dose of 300 mg as the initial dose, followed by 150 mg once weekly. If the patient weighs 50 kg or more and shows an inadequate response, the dose may be increased to 300 mg once weekly for subcutaneous administration.

Interventions

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Marstacimab

For patients aged 12 years or older and weighing at least 35 kg, marstacimab is administered subcutaneously at a dose of 300 mg as the initial dose, followed by 150 mg once weekly. If the patient weighs 50 kg or more and shows an inadequate response, the dose may be increased to 300 mg once weekly for subcutaneous administration.

Intervention Type DRUG