Factor Product Utilization and Health Outcomes in Patients With Hemophilia
NCT ID: NCT02796222
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
61 participants
OBSERVATIONAL
2016-04-30
2021-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
NCT01425723
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
NCT02392156
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
NCT02053792
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
NCT01662531
Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
NCT01027377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hemophilia A patients on rFVIIIFc
Patients with hemophilia A who switch from on-demand or prophylactic treatment with rFVIII to rFVIIIFc
No interventions assigned to this group
Hemophilia A patients on rFVIII
Patients with hemophilia A who remain on on-demand or prophylactic treatment with rFVIII
No interventions assigned to this group
Hemophilia B patients on rFIXFc
Patients with hemophilia B who switch from on-demand or prophylactic treatment with rFIX to rFIXFc
No interventions assigned to this group
Hemophilia A patients on rFIX
Patients with hemophilia B who remain on on-demand or prophylactic treatment with rFIX
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or assent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations.
Exclusion Criteria
2. Patients with an existing bleeding disorder other than hemophilia A or B
3. History of hypersensitivity or severe allergic reactions to factor products
4. Patients currently participating in a phase 1-3 study with another factor replacement product
5. Unable to adhere to the study requirements based on the judgment of the Prescribing Physician (e.g. unable to enter accurate and timely infusion and bleeding records)
12 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shannon Jackson
Clinical Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shannon Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Hematology, Department of Medicine, University of British Columbia
Robert Klaassen, MD
Role: STUDY_CHAIR
Division of Hematology/Oncology, Department of Pediatrics, University of Ottawa
Man-Chiu Poon, MD
Role: STUDY_CHAIR
Division of Hematology, Department of Medicine, University of Calgary
Sue Robinson, MD
Role: STUDY_CHAIR
Division of Hematology, Department of Medicine, Dalhousie University
John Wu, MD
Role: STUDY_CHAIR
BC Children's hospital, Division of Hematology, Department of Medicine, University of British Columbia
Alfonso Iorio, MD
Role: STUDY_CHAIR
Hemophilia Program, Hamilton Health Services Program, McMaster University
Michelle Sholzberg, MD
Role: STUDY_CHAIR
Hemophilia Program, St. Michael's Hospital, University of Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BC Hemophilia Adult Program
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAN-FAB-15-10911
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.