CompletedNot Applicable

Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

United States50 participantsStarted 2016-12-14

Plain-language summary

The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult participant (or legal representative) is willing to provide informed consent * Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice Exclusion Criteria: * Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections * Participant has participated in a 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 at study entry

What they're measuring

Number of AEs and SAEs including seriousness, severity and outcome

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of thromboembolic events

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of dose dispensing medication errors

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Trial details

NCT IDNCT03199794

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-07-30

View on ClinicalTrials.gov More Acquired Hemophilia A trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of AEs and SAEs including seriousness, severity and outcome

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of thromboembolic events

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.

Number of dose dispensing medication errors

Timeframe: From first administration of Obizur up to 180 days after the last administration of Obizur.