CompletedNot Applicable

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

United States, Austria, France50 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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.