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

Baxalta

Status: Completed

Conditions: Acquired Hemophilia A

Treatments: Biological: OBIZUR

Study type: Observational

Funder types: Industry

Identifiers

NCT02610127

EUPAS36659 (Registry Identifier)

241302

Details and patient eligibility

About

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.

Full description

This study is a multi-center, uncontrolled, open-label, non-interventional post-marketing safety surveillance study to describe the use of Obizur in patients with acquired hemophilia A (AHA), and secondarily, where data are available, to describe the hemostatic effectiveness and immunogenicity of Obizur.

Patients should be enrolled at the earliest possible time point after initiating Obizur.

In an attempt to collect safety and utilization data on patients treated with Obizur since Food and Drug Administration (FDA) approval in October 2014, Baxalta will make an effort to identify all persons treated with Obizur and to collect data for as many patients as possible.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein.
2. Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
3. 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.

Trial design

53 participants in 2 patient groups

OBIZUR - Prospective Participants

Description:

Participants enrolled and treated with Obizur after the prospective study start date

Treatment:

Biological: OBIZUR

OBIZUR - Retrospective Participants

Description:

Retrospective chart review of participants treated with OBIZUR from product approval date until prior to the prospective study start date

Treatment:

Biological: OBIZUR