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Trials / Active Not Recruiting

Active Not RecruitingNCT07161687

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

HYMPAVZI S.C. INJECTION 150 mg Pen SPECIAL INVESTIGATION

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Pfizer · Industry
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMarstacimabFor 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.

Timeline

Start date
2025-10-30
Primary completion
2030-04-11
Completion
2030-04-11
First posted
2025-09-09
Last updated
2026-03-30

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT07161687. Inclusion in this directory is not an endorsement.