CompletedNot Applicable

Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A

United States53 participantsStarted 2015-12-30

Plain-language summary

The overall objective is to enroll patients with acquired hemophilia A (AHA) who are prescribed and treated with Obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant is ≥18 years of age at the time of informed consent.
✓. Participant has AHA, and is being treated/was treated with Obizur.
✓. Participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required

Exclusion criteria

✕. Participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein.
✕. Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
✕. Participant 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.

What they're measuring

Incidence of therapy-related SAEs and level of severity

Timeframe: Throughout the study period of approximately 4 years

Trial details

NCT IDNCT02610127

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06-07

View on ClinicalTrials.gov More Acquired Hemophilia A trials