Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06550882 | NOT YET RECRUITING | Acquired Hemophilia A

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

Takeda

Brief 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. 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.

Condition or disease

Acquired Hemophilia A

Intervention/treatment

OBIZUR

Detailed Description:

This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.

Study Type : OBSERVATIONAL
Estimated Enrollment : 9 participants
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
Actual Study Start Date : 2024-12-31
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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.
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea

Location Details

NCT06550882

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found