Actively Recruiting

All Genders
ID06461533

General Use-results Survey of OBIZER for Intravenous Injection in Acquired Hemophilia A

Led by Takeda · Updated on 2026-05-22

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a survey in Japan to study the use of Susoctocog Alfa (Genetical Recombination) intravenous injection in participants with bleeding events caused by acquired Hemophilia A (AHA). The study aims to monitor side effects related to this treatment and assess its impact on bleeding events in those affected by AHA. The sponsor provides guidelines for clinic data recording but does not influence the treatment methods. Participants will receive Susoctocog Alfa (Genetical Recombination) through intravenous injection following their clinic's usual care practices. The study does not alter how the treatment is given but observes its use in real-world settings. Participants will be followed for side effects and treatment effects during their care. During the study, doctors will monitor participants for any treatment-related side effects up to 90 days after the last dose or until the participant stops treatment. Researchers will collect data on adverse events and evaluate the effectiveness of the treatment on bleeding episodes. The total duration of monitoring varies by participant, based on their treatment timeline and study discontinuation status.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All participants with Acquired Haemophilia A treated with Susoctocog Alfa (Genetical Recombination).
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From first dose until up to 90 days after the last dose or until discontinuation, whichever comes first (varies by participant).

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

Visits occur from first dose through 90 days post last dose depending on participant's treatment duration

Follow-up

Duration - Up to 90 days after last dose or until discontinuation (varies by participant).

Participants are monitored for adverse events and treatment effectiveness for up to 90 days after the last dose of Susoctocog Alfa or until discontinuation.

Follow-up visits depending on participant's treatment course

Trial Site Locations

Total: 1 location

1

Takeda selected site

Tokyo, Tokyo, Japan

Actively Recruiting

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Research Team

T

Takeda Contact

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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