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

Not yet recruiting

• Conditions: Hemophilia A or B
• Interventions: Drug: Marstacimab

• Registration Number: NCT07161687
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-09-30
• Primary Completion: 2029-12-13
• Study Completion: 2029-12-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Marstacimab	Marstacimab	hemophilia patients without inhibitor

Primary Outcome Measures

Name	Time	Method
Number of the participants with adverse drug reactions	The evaluation period is from the first dose of Himpavzi up to 156 weeks (3 years).	An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Himpavzi in a participant who received Himpavzi. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Himpavzi was assessed by the physician.