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NCT06550882

A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea

StatusRecruiting
PhaseNot specified
SponsorTakeda
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 3 months later across 2 updates.

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Record History

All 11 versions: 11 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2028 Show 5 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Primary endpoints: details revised at 1 of 4 entries
    • Enrollment increased: 9 → 11 participants
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 2 of 4 sites
  2. Primary and study completion pushed from Sep 30, 2026 to Dec 31, 2026v10
  3. Study sites: 1 to 4v9
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 31, 2025 to Jul 22, 2025
    v8
  5. Start date: May 30, 2025 to Jul 31, 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Mar 30, 2025 to May 30, 2025v6
  2. Start date: Feb 28, 2025 to Mar 30, 2025v5
  3. Start date: Dec 31, 2024 to Feb 28, 2025v4
  4. Start date: Sep 30, 2024 to Dec 31, 2024v3
  5. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Timeframe: Up to 3 months
Number of Participants With Expected/Unexpected AEs and SAEs
Timeframe: Up to 3 months
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
Timeframe: Up to 3 months
Number of Participants With Special Situation Report (SSR)
Timeframe: Up to 3 months

Secondary (5)

Percentage of Participants With Overall Bleeding Control
Time to Achieve Bleeding Control With OBIZUR Injection
Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
Dose of OBIZUR Required to Stop the Bleeding
Percentage of Participants With Bleeding Events

Arms and interventions

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.

Drugs: OBIZUR

Sites

4 sites in 1 country