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

Baxalta

Status: Completed

Conditions: Acquired Hemophilia A

Treatments: Biological: OBIZUR

Study type: Observational

Funder types: Industry

Identifiers

NCT03199794

241501

EUPAS16055 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

OBIZUR participants

Description:

Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.

Treatment:

Biological: OBIZUR