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Completed

NCT Number: NCT03199794

Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

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Key information

Conditions

Acquired Hemophilia A Factor 8 deficiency, acquired

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AKH - Medizinische Universität Wien, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult participant (or legal representative) is willing to provide informed consent
  • Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice

Exclusion criteria

  • Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections
  • Participant has participated in a 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 at study entry

Treatment and study plan

OBIZUR

Biological

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

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

Primary outcomes

  1. Number of AEs and SAEs including seriousness, severity and outcome

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    AE - adverse event, SAE - serious adverse event.

  2. Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Adverse Events of Special Interest (AESI) are as follows: hypersensitivity reactions, thromboembolic events and dose dispensing medication errors.

  3. Number of thromboembolic events

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Thromboembolic events include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke.

  4. Number of dose dispensing medication errors

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Dose dispensing medication erros include miscalculation of dose while prescribing (calculation of correct dose based on the participant's weight) or administration of the incorrect dose.

Secondary outcomes

  1. Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

  2. Obizur treatment regimen, as available

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    This may include details of the Obizur treatment regimen utilized, as available

  3. Other medication administered for haemostatic control, as available

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode.

  4. Overall effectiveness assessment for resolution of bleeding

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Resolution of bleeding determined as either bleeding stopped or did not stop. If bleeding did not stop, a reason should be provided.

  5. Dose per infusion administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Bleeding control defined as all bleeding stopped.

  6. Number of infusions administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Bleeding control defined as all bleeding stopped.

  7. Time to achieve bleeding control, death or change in haemostatic treatment other than Obizur

    Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.

    Bleeding control defined as all bleeding stopped.

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
2016
Primary completion
2021
Study completion
2021
First posted
Jun 27, 2017
Registry last updated
Jul 21, 2022

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.

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