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

Acquired Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610127
• Other study ID #: 241302
• Secondary ID: EUPAS36659
• Status: Completed
• Start date: December 30, 2015
• Est. completion date: June 7, 2019

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Hemophilia A
• Hemophilia A

Intervention

Biological:
• OBIZUR
Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado Health	Aurora	Colorado
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	University of Florida	Gainesville	Florida
United States	Indiana Hemophilia and Thrombosis Center	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	Blood Center of Southeast Wisconsin	Milwaukee	Wisconsin
United States	Tulane University Hospital & Clinics	New Orleans	Louisiana
United States	Bleeding and Clotting Disorders Institute	Peoria	Illinois
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Comprehensive Cancer Center of Wake Forest Unversity	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Baxalta now part of Shire	Baxalta Innovations GmbH, now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of therapy-related SAEs and level of severity		Throughout the study period of approximately 4 years
Secondary	Hemostatic effectiveness assessment for resolution of bleeding	Determined as either bleeding stopped or did not stop	Throughout the study period, up to approximately 4 years
Secondary	Time to bleeding resolution, participant study termination, or switch to another treatment		Throughout the study period, up to approximately 4 years
Secondary	Number of Obizur units/kg required for control of bleeding		Throughout the study period, up to approximately 4 years
Secondary	Number of Obizur infusions required for control of bleeding		Throughout the study period, up to approximately 4 years
Secondary	Titer of newly recognized anti-porcine Factor VIII (anti-pFVIII) neutralizing antibodies (inhibitors) or increase in titer of anti-pFVIII inhibitors from baseline and changes over time.		Throughout the study period of approximately 4 years
Secondary	Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations.		Throughout the study period of approximately 4 years
Secondary	Occurrence of hypersensitivity reactions		Throughout the study period of approximately 4 years
Secondary	Occurrence of any thrombogenic event		Throughout the study period of approximately 4 years

External Links

•   To obtain more information on the study, click here/on this link