A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
HIZ
HYMPAVZI S.C. INJECTION 150 mg Pen SPECIAL INVESTIGATION
1 other identifier
observational
50
1 country
1
Brief Summary
A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedStudy Start
First participant enrolled
October 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 11, 2030
March 30, 2026
March 1, 2026
4.4 years
September 2, 2025
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of the participants with adverse drug reactions
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.
The evaluation period is from the first dose of Himpavzi up to 156 weeks (3 years).
Study Arms (1)
Marstacimab
hemophilia patients without inhibitor
Interventions
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.
Eligibility Criteria
All patients who have received at least one dose of this drug after the launch of this drug.
You may qualify if:
- Patients who have received at least one dose of this drug after the launch of this drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2025
First Posted
September 9, 2025
Study Start
October 30, 2025
Primary Completion (Estimated)
April 11, 2030
Study Completion (Estimated)
April 11, 2030
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.