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

July 18, 2022 updated by: Baxalta now part of Shire
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Akh - Medizinische Universität Wien
  • France
      • Rouen, France, 76000
        • CHU de Rouen - Hôpital Charles Nicolle
  • Germany
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn
      • Dresden, Germany, 01304
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Frankfurt, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universitaet
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
  • Italy
      • Alessandria, Italy, 15100
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Pugliese Ciaccio
      • Palermo, Italy, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Rome, Italy, 00161
        • Umberto I Pol. di Roma-Università di Roma La Sapienza
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Radboud University Medical Centre
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospital Birmingham
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
      • Southampton, United Kingdom, SO16 5YA
        • Southampton General Hospital
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida - Shands
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44103
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A participant with acquired hemophilia (AH) must be prescribed Obizur for the treatment of a bleeding episode by a physician, independent of and prior to the decision to enrol the participant in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OBIZUR participants
Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
Biological: OBIZUR
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
Other Names:
  • Antihemophilic Factor (Recombinant)
  • rpFVIII
  • Recombinant pFVIII
  • Porcine Sequence

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxalta now part of Shire

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxalta Innovations GmbH, now part of Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 241501
  • EUPAS16055 (Registry Identifier: ENCePP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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