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

Baxalta now part of Shire53 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acquired Hemophilia A

Interventions

OBIZURBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

University of Colorado Health

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Incidence of therapy-related SAEs and level of severity

Time frame: Throughout the study period of approximately 4 years

Secondary Outcomes

Hemostatic effectiveness assessment for resolution of bleeding

Determined as either bleeding stopped or did not stop

Time frame: Throughout the study period, up to approximately 4 years

Time to bleeding resolution, participant study termination, or switch to another treatment

Time frame: Throughout the study period, up to approximately 4 years

Number of Obizur units/kg required for control of bleeding

Time frame: Throughout the study period, up to approximately 4 years

Number of Obizur infusions required for control of bleeding

Time frame: Throughout the study period, up to approximately 4 years

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.

Time frame: Throughout the study period of approximately 4 years

Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations.

Time frame: Throughout the study period of approximately 4 years

Occurrence of hypersensitivity reactions

Time frame: Throughout the study period of approximately 4 years

Occurrence of any thrombogenic event

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.