A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A

NCT ID: NCT06461533

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2029-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Acquired Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Susoctocog Alfa (Genetical Recombination)

Participants will receive Susoctocog Alfa (Genetical Recombination) intravenous injection.

Susoctocog Alfa (Genetical Recombination)

Intervention Type DRUG

Susoctocog Alfa (Genetical Recombination), Intravenous injection

Interventions

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Susoctocog Alfa (Genetical Recombination)

Susoctocog Alfa (Genetical Recombination), Intravenous injection

Intervention Type DRUG

Other Intervention Names

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OBIZUR Intravenous Injection 500 TAK-672

Eligibility Criteria

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Inclusion Criteria

\- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda selected site

Tokyo, Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Takeda Site

Role: primary

Site

Role: backup

Other Identifiers

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TAK-672-4004

Identifier Type: -

Identifier Source: org_study_id

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