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

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ClinicalTrials.gov Identifier: NCT03199794
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
Baxalta Innovations GmbH, now part of Shire
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Tracking Information
First Submitted Date June 23, 2017
First Posted Date June 27, 2017
Last Update Posted Date November 4, 2019
Actual Study Start Date December 14, 2016
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03199794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 23, 2017)
  • 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. ]
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice
Official Title Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acquired Hemophilia A
Intervention Biological: OBIZUR
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)
Study Groups/Cohorts OBIZUR participants
Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
Intervention: Biological: OBIZUR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com
Listed Location Countries Austria,   Germany,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03199794
Other Study ID Numbers 241501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. 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.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers
Responsible Party Shire ( Baxalta now part of Shire )
Study Sponsor Baxalta now part of Shire
Collaborators Baxalta Innovations GmbH, now part of Shire
Investigators
Study Director: Study Director Shire
PRS Account Shire
Verification Date November 2019