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

Acquired Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199794
• Other study ID #: 241501
• Secondary ID: EUPAS16055
• Status: Completed
• Start date: December 14, 2016
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Hemophilia A
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
Austria	AKH - Medizinische Universität Wien	Vienna
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt
Germany	Medizinische Hochschule Hannover	Hannover
Italy	Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Azienda Ospedaliera Pugliese Ciaccio	Catanzaro
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Umberto I Pol. di Roma-Università di Roma La Sapienza	Rome
Italy	Istituto Clinico Humanitas	Rozzano
Netherlands	Radboud University Medical Centre	Nijmegen
United Kingdom	University Hospital Birmingham	Birmingham
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Royal Free Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Southampton General Hospital	Southampton
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida - Shands	Gainesville	Florida
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of AEs and SAEs including seriousness, severity and outcome	AE - adverse event, SAE - serious adverse event.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Primary	Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation	Adverse Events of Special Interest (AESI) are as follows: hypersensitivity reactions, thromboembolic events and dose dispensing medication errors.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Primary	Number of thromboembolic events	Thromboembolic events include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Primary	Number of dose dispensing medication errors	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.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time		From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Obizur treatment regimen, as available	This may include details of the Obizur treatment regimen utilized, as available	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Other medication administered for haemostatic control, as available	This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Overall effectiveness assessment for resolution of bleeding	Resolution of bleeding determined as either bleeding stopped or did not stop. If bleeding did not stop, a reason should be provided.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Dose per infusion administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur	Bleeding control defined as all bleeding stopped.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Number of infusions administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur	Bleeding control defined as all bleeding stopped.	From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary	Time to achieve bleeding control, death or change in haemostatic treatment other than Obizur	Bleeding control defined as all bleeding stopped.	From first administration of Obizur up to 180 days after the last administration of Obizur.

External Links

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