NCT02610127

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acquired Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	OBIZUR	Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.

Timeline

• Start date: 2015-12-30
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2015-11-20
• Last updated: 2021-08-05

Locations

16 sites across 1 country: United States