Acquired Hemophilia ANCT06461533
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
An observational study of Acquired Hemophilia A, run by Takeda at 1 site in Japan.
Trial summary
This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Hemophilia A
- What is being tested?
- Susoctocog Alfa (Genetical Recombination)
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jun 2024to 31 May 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)
This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.
During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).
- Conditions
- Acquired Hemophilia A
- Being tested
- Susoctocog Alfa (Genetical Recombination)
- Medical subject headings
- Factor 8 deficiency, acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Susoctocog Alfa (Genetical Recombination)Drug
Also called OBIZUR Intravenous Injection 500, TAK-672
Susoctocog Alfa (Genetical Recombination), Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Susoctocog Alfa (Genetical Recombination) | Participants will receive Susoctocog Alfa (Genetical Recombination) intravenous injection. Receives: Drug: Susoctocog Alfa (Genetical Recombination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Measured: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
Secondary outcomes (2)
Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG scale will be used to assess performance status of participants. ECOG is a grade, where grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead.
Measured: Pre-dose, at the last dose or discontinuation of study drug, whichever came first, and 90 days after the last dose or discontinuation of study drug, whichever came first (varied from participant to participant)
Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator
Number of participants for categories of treatment effectiveness with Susoctocog Alfa (Genetical Recombination) will be reported. Investigator will assess participants with following categories; Effective (Bleeding stopped and Clinically controlled), Partially Effective (Blood loss decreased, and Clinically stable, improvement, or bleeding for the other reason), Ineffective (Blood loss slightly decreased or unchanged and Clinically unstable), Not Effective (Worsening of bleeding and Clinically worsening).
Measured: 24 hours after the first dose of study drug, and the last dose for bleeding episode or discontinuation of study drug, whichever came first (varied from participant to participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start10 Jun 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Hemophilia AStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461533
- Sponsor's protocol ID
- TAK-672-4004
- Other IDs
- jRCT2031240148
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)
- ClinicalTrials.gov ID
- NCT06461533
- Acronym / sponsor ID
- TAK-672-4004
- Conditions
- Acquired Hemophilia A
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 17 Jun 2024 (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.
This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.
During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Susoctocog Alfa (Genetical Recombination) | – | Drug: Susoctocog Alfa (Genetical Recombination)Participants will receive Susoctocog Alfa (Genetical Recombination) intravenous injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this survey are all participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Susoctocog Alfa (Genetical Recombination)Also: OBIZUR Intravenous Injection 500, TAK-672Susoctocog Alfa (Genetical Recombination), Intravenous injection | Drug | Susoctocog Alfa (Genetical Recombination) |
Primary outcome
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Time frame: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Time frame: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
2 secondary outcomes
Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Pre-dose, at the last dose or discontinuation of study drug, whichever came first, and 90 days after the last dose or discontinuation of study drug, whichever came first (varied from participant to participant)
Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator
Time frame: 24 hours after the first dose of study drug, and the last dose for bleeding episode or discontinuation of study drug, whichever came first (varied from participant to participant)
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 7 Aug 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
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 Acquired Hemophilia A, run by Takeda 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 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?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) (time frame: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)). The study lists 2 primary outcomes in all. 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 7 Aug 2026.