Acquired Hemophilia ANCT06550882
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
An observational study of Acquired Hemophilia A, run by Takeda at 4 sites in South Korea.
Trial summary
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hemophilia A
- What is being tested?
- OBIZUR
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 22 Jul 2025to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.
Who may be able to join
- Participants with AHA.
- Participants who are determined to have the clinical need to receive Obizur treatment.
- Participants aged 18 years or older at time of initiation of Obizur treatment.
- Participants agreed to participate in the study and voluntarily signed the informed consent.
Who cannot join
- Participants with hypersensitivity to any of the components of this drug.
- Participants with Congenital Hemophilia A with Inhibitors (CHAWI).
- Participants for whom Obizur treatment is contraindicated as per product label.
- Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Site contact, pysped@khu.ac.kr
Young Shil Park, Ph.D
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Site Contact, +82-2-2258-5745, royoon@catholic.ac.kr
Jae-ho Yoon
- Recruiting
Ewha Womans University Medical Center
Seoul, 07804
Site Contact, +82-2-6986-3100, anemia@khu.ac.kr
Jae-joon Han
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Site Contact, +82-52-250-7000, yjleeh@uuh.ulsan.kr
Yoo Jin Lee
About this study
Official title: Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA.
The main aim of the study is to learn how safe OBIZUR is in adults with AHA.
Read more
Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting.
The treatment of the participants will be determined by the treating physicians.
During the study, data already existing in the participants' medical record and new data will be collected.
Read the detailed description
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
- Conditions
- Acquired Hemophilia A
- Being tested
- OBIZUR
- Keywords
- Drug Therapy
- 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.
OBIZURDrug
Also called Susoctocog Alpha, Porcine Antihemophilic factor VIII, Recombinant, TAK-672
OBIZUR injection.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with AHA who are receiving OBIZUR injection or initiate OBIZUR Injection treatment for the first time will be enrolled. Both retrospective and prospective participants data will be collected. Retrospective data will be collected from the date of first treatment with OBIZUR injection after the marketing authorization in Korea but before date of signed informed consent and prospective data will be collected from the date of signed informed consent. The treatment and follow up of the participants will be determined by the treating physicians according to her/his routine practice. Receives: Drug: OBIZUR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Measured: Up to 3 months
Number of Participants With Expected/Unexpected AEs and SAEs
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Measured: Up to 3 months
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Measured: Up to 3 months
Number of Participants With Special Situation Report (SSR)
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit.
Measured: Up to 3 months
Secondary outcomes (5)
Percentage of Participants With Overall Bleeding Control
Overall Bleeding Control will be determined as either bleeding stopped or did not stop.
Measured: Up to 3 months
Time to Achieve Bleeding Control With OBIZUR Injection
Time to achieve bleeding control will be assessed from initiation of OBIZUR Injection (start time) to the time to achieve bleeding control (stop time).
Measured: Up to 3 months
Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
Number of OBIZUR injection infusion required to achieve bleeding control will be reported.
Measured: Up to 3 months
Dose of OBIZUR Required to Stop the Bleeding
OBIZUR dose required to stop the bleeding will be reported.
Measured: Up to 3 months
Percentage of Participants With Bleeding Events
Bleeding events will be evaluated and reported as re-bleed, concurrent bleed and subsequent bleed. Re-bleed: if it occurs in the same anatomical location and within 72 hours of the resolution of the previous bleeding. Concurrent bleed: if it occurs at the same time (that is, during treatment or within 72 hours of resolution) as previous bleed but at a different anatomical location. Subsequent bleed: if it is a new bleed occurring 72 hours after the resolution of the previous bleed (either in the same anatomical location or in a new one).
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start22 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Other
- Enrolment
- 9 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
- NCT06550882
- Sponsor's protocol ID
- TAK-672-4002
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea
- ClinicalTrials.gov ID
- NCT06550882
- Acronym / sponsor ID
- TAK-672-4002
- Conditions
- Acquired Hemophilia A
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 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.
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA.
The main aim of the study is to learn how safe OBIZUR is in adults with AHA.
Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting.
The treatment of the participants will be determined by the treating physicians.
During the study, data already existing in the participants' medical record and new data will be collected.
Detailed description
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: OBIZURParticipants with AHA who are receiving OBIZUR injection or initiate OBIZUR Injection treatment for the first time will be enrolled. Both retrospective and prospective participants data will be collected. Retrospective data will be collected from the date of first treatment with OBIZUR injection after the marketing authorization in Korea but before date of signed informed consent and prospective data will be collected from the date of signed informed consent. The treatment and follow up of the participants will be determined by the treating physicians according to her/his routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.
Key inclusion criteria (4 listed)
- Participants with AHA.
- Participants who are determined to have the clinical need to receive Obizur treatment.
- Participants aged 18 years or older at time of initiation of Obizur treatment.
- Participants agreed to participate in the study and voluntarily signed the informed consent.
Key exclusion criteria (4 listed)
- Participants with hypersensitivity to any of the components of this drug.
- Participants with Congenital Hemophilia A with Inhibitors (CHAWI).
- Participants for whom Obizur treatment is contraindicated as per product label.
- Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
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 |
|---|---|---|
| OBIZURAlso: Susoctocog Alpha, Porcine Antihemophilic factor VIII, Recombinant, TAK-672OBIZUR injection. | Drug | All Participants |
Primary outcome
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Time frame: Up to 3 months
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Number of Participants With Expected/Unexpected AEs and SAEs
Time frame: Up to 3 months
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
Time frame: Up to 3 months
An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Special Situation Report (SSR)
Time frame: Up to 3 months
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit.
5 secondary outcomes
Percentage of Participants With Overall Bleeding Control
Time frame: Up to 3 months
Time to Achieve Bleeding Control With OBIZUR Injection
Time frame: Up to 3 months
Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
Time frame: Up to 3 months
Dose of OBIZUR Required to Stop the Bleeding
Time frame: Up to 3 months
Percentage of Participants With Bleeding Events
Time frame: Up to 3 months
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 11 Sep 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
4 sites 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 4 sites in South Korea.
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 4 inclusion and 4 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) (time frame: Up to 3 months). The study lists 4 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 11 Sep 2026.