Combining Registry Data in Haemophilia: TARGET H

Haemophilia Clinical Trial

— TARGET-H  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264014
• Other study ID #: UP TARGET H
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: August 24, 2017
• Start date: May 2015
• Est. completion date: September 30, 2015

Study information

• Verified date: August 2017
• Source: University of Pretoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemophilia registry data	sosiodemographic parameters, disease parameters and treatment and disease outcome parameters	May to September 2015