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

Purpose

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.

Condition

  • Acquired Hemophilia A

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
OBIZUR participants Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
  • Biological: OBIZUR
    Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
    Other names:
    • Recombinant pFVIII
    • Porcine Sequence
    • rpFVIII
    • Antihemophilic Factor (Recombinant)

More Details

Status
Completed
Sponsor
Baxalta now part of Shire

Study Contact