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NCT Number: NCT06461533

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

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).

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Key information

Conditions

Acquired Hemophilia A Factor 8 deficiency, acquired

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Location status: Recruiting

Location contact

Takeda Selected Site

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Susoctocog Alfa (Genetical Recombination)

Drug

Susoctocog Alfa (Genetical Recombination), Intravenous injection

Other names: OBIZUR Intravenous Injection 500, TAK-672

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 17, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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