NCT02776826

Brief Summary

The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

May 11, 2016

Last Update Submit

October 27, 2017

Conditions

Hemophilia A and B

Outcome Measures

Primary Outcomes (4)

  • Proportion of HTCs which agree to participate in the pilot phase of the WBDR

    This is be measured by the number of HTCs who agree to participate, divided by the number of HTCs invited.

    6 months

  • Proportion of participating HTCs who successfully obtain necessary regulatory approval

    This will be measured by the number of HTCs who obtain approval, divided by the number of HTCs who have agreed to participate in the pilot phase of the WBDR.

    6 months

  • Proportion of patients who agree to participate in this pilot phase of the WBDR.

    This will be measured by the number of patients who provided consent to participate, divided by the number of patients who were approached to participate.

    6 months

  • Proportion of enrolled patients on which data collection and database entry is successful.

    This will be measured by the number of patients on who data is collected and entered successfully into the database, divided by the number of patients who are enrolled in the pilot phase of the WBDR.

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hemophilia A or B, who are patients of participating Hemophilia Treatment Centres.

You may qualify if:

  • Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.
  • Ability to provide data in English

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 18, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 31, 2017

Record last verified: 2017-10