TARGET-H: Combining Registry Data in Haemophilia: TARGET H

Sponsor

University of Pretoria (Other)

Overall Status

Completed

CT.gov ID

NCT03264014

Collaborator

Novo Nordisk A/S (Industry), Medical Research Council, South Africa (Other)

100

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia registry. Data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.The aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.

Condition or Disease	Intervention/Treatment	Phase
Haemophilia

Detailed Description

The study is conducted in five haemophilia treatment centres (HTCs) from different geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local or national haemophilia registry. Data will be collected from 20 randomly selected, active patient records from each participating registry/country. In countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. Participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. In addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. Analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. Feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

An Observational Pilot sTudy to Assess the Feasibility of Combining Data From Patient Registries in Countries With Developing Health Care Systems to EvaluaTe Haemophilia Management

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 30, 2015

Outcome Measures

Primary Outcome Measures

Haemophilia registry data [May to September 2015]
sosiodemographic parameters, disease parameters and treatment and disease outcome parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

male
diagnosis of haemophilia A or B
with or without inhibitors
no other inherited bleeding disorder
active patient record
willing and able to provide written consent

Exclusion Criteria:

unwilling or unable to provide written consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Pretoria
Novo Nordisk A/S
Medical Research Council, South Africa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joachim Potgieter, Dr., University of Pretoria

ClinicalTrials.gov Identifier:

NCT03264014

Other Study ID Numbers:

UP TARGET H

First Posted:

Aug 28, 2017

Last Update Posted:

Aug 28, 2017

Last Verified:

Aug 1, 2017

Additional relevant MeSH terms:

Hemophilia A

Study Results

No Results Posted as of Aug 28, 2017