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NCT Number: NCT07161687

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hemophilia A or B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Patients who have received at least one dose of this drug after the launch of this drug

Treatment and study plan

Marstacimab

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.

Other names: Hympavzi

Primary outcomes

  1. Number of the participants with adverse drug reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

HYMPAVZI S.C. INJECTION 150 mg Pen SPECIAL INVESTIGATION

Acronym: HIZ

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 9, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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