Skip to main content
OpenTrials
Completed

NCT Number: NCT02610127

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Health, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

OBIZUR

Biological

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

Other names: rpFVIII, Recombinant pFVIII, Antihemophilic Factor (Recombinant), Porcine Sequence

Primary outcomes

  1. Incidence of therapy-related SAEs and level of severity

    Time frame: Throughout the study period of approximately 4 years

Secondary outcomes

  1. 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

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

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

  3. Number of Obizur units/kg required for control of bleeding

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

  4. Number of Obizur infusions required for control of bleeding

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

  5. 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

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

    Time frame: Throughout the study period of approximately 4 years

  7. Occurrence of hypersensitivity reactions

    Time frame: Throughout the study period of approximately 4 years

  8. Occurrence of any thrombogenic event

    Time frame: Throughout the study period of approximately 4 years

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

  • Baxalta Innovations GmbH, now part of Shire

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2015
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.