Hemophilia A or BHIZNCT07161687
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
An observational study of Hemophilia A or B, run by Pfizer at 1 site in Japan.
Trial summary
A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A or B
- What is being tested?
- Marstacimab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 30 Oct 2025to 11 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have received at least one dose of this drug after the launch of this drug.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYMPAVZI S.C. INJECTION 150 MG PEN SPECIAL INVESTIGATION
A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors.
Read the 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
- Hemophilia A or B
- Being tested
- Marstacimab
- Keywords
- Marstacimab,Hympavzi,Hemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarstacimabDrug
Also called Hympavzi
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.
| Study group | Role | What they receive |
|---|---|---|
| Marstacimab | hemophilia patients without inhibitor Receives: Drug: Marstacimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The evaluation period is from the first dose of Himpavzi up to 156 weeks (3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start30 Oct 2025
- Primary completion11 Apr 2030 (estimated)
- Study completion11 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A or BStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161687
- Sponsor's protocol ID
- B7841012
- Acronym
- HIZ
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYMPAVZI S.C. INJECTION 150 MG PEN SPECIAL INVESTIGATION
- ClinicalTrials.gov ID
- NCT07161687
- Acronym / sponsor ID
- HIZ / B7841012
- Conditions
- Hemophilia A or B
- Keywords
- Marstacimab,Hympavzi,Hemophilia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 11 Apr 2030 (estimated)
- Study completion
- 11 Apr 2030 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marstacimab | – | Drug: Marstacimabhemophilia patients without inhibitor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have received at least one dose of this drug after the launch of this drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MarstacimabAlso: HympavziFor 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. | Drug | Marstacimab |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Hemophilia A or B
Not yet recruitingObservational study
A Study to Describe Patient REal-world FitusiRan ExpeRience
Hemophilia A or B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
Not yet recruitingPhase 3
A Phase III Clinical Trial Evaluating SR604 Injection for Prophylactic Treatment in Patients With Hemophilia
Hemophilia A, Hemophilia A and B
RecruitingPhase 3
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
Hemophilia A, Hemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A or B, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.