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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary:

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, but within ten days of initiating Obizur to ensure unbiased prospective observation.

In addition, in an attempt to collect all safety and utilization data on patients treated with Obizur since Food and Drug Administration approval, Baxalta will conduct a retrospective chart review on persons treated with Obizur prior to the prospective study start date (Retrospective study participants may or may not also participate in the prospective portion of the study).


Sponsor: Baxalta US Inc.

Current Primary Outcome: Incidence of therapy-related SAEs and level of severity [ Time Frame: Throughout the study period of approximately 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hemostatic effectiveness assessment for resolution of bleeding [ Time Frame: Throughout the study period, up to approximately 4 years ]
    Determined as either bleeding stopped or did not stop
  • 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 [ Time Frame: Throughout the study period of approximately 4 years ]


Original Secondary Outcome: Same as current

Information By: Baxalta US Inc.

Dates:
Date Received: October 29, 2015
Date Started: December 2015
Date Completion: November 2019
Last Updated: August 16, 2016
Last Verified: August 2016