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World Bleeding Disorders Registry (WBDR)

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ClinicalTrials.gov Identifier: NCT03327779
Recruitment Status : Not yet recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
World Federation of Hemophilia

Tracking Information
First Submitted Date October 27, 2017
First Posted Date October 31, 2017
Last Update Posted Date October 31, 2017
Estimated Study Start Date January 2018
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2017)
  • Number of participants recruited [ Time Frame: 5 years ]
  • Number of participating Hemophilia Treatment Centres [ Time Frame: 5 years ]
  • Number of participating countries [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title World Bleeding Disorders Registry
Official Title World Bleeding Disorders Registry
Brief Summary The WBDR is an international observational disease registry of patients with hemophilia. It will provide a platform for a network of hemophilia treatment centres (HTCs) around the world to collect uniform and standardized patient data and guide clinical practice. With informed consent from the patient, the WBDR stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.
Detailed Description

The WBDR is a prospective, global registry of patients diagnosed with hemophilia A and B. Following the success of a pilot study, implementation of the full scale WBDR is underway. The goals are to enroll at least 200 HTCs from more than 50 countries, and at least 10,000 people with hemophilia, during the first five years, aiming for representation of patients from around the world and from all levels of access to care. Minimal criteria for participation of HTCs include access to reliable internet, human resources for data entry and commitment to long-term enrolment and follow-up of patients. The WBDR database is being developed through a collaboration between the WFH, Karolinska Institute and Health Solutions.

By combining data from countries around the world, the WBDR will provide a large amount of real world data, on which researchers can address important scientific and clinical issues. The World Bleeding Disorders Registry (WBDR) is intended to fill existing gaps in knowledge by collecting real world data on the patient clinical experience around the globe.

Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients of participating Hemophilia Treatment Centres with Hemophilia A or B
Condition
  • Hemophilia A
  • Hemophilia B
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Not yet recruiting
Estimated Enrollment
 (submitted: October 27, 2017)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2028
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients of participating Hemophilia Treatment Centres with Hemophilia A or B

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03327779
Other Study ID Numbers WBDR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party World Federation of Hemophilia
Study Sponsor World Federation of Hemophilia
Collaborators Not Provided
Investigators Not Provided
PRS Account World Federation of Hemophilia
Verification Date October 2017