Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Congenital Bleeding Disorder Clinical Trial

— HAEMOcare  

Official title:

Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503567
• Other study ID #: HAEM-3971
• Secondary ID: U1111-1124-6665
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: January 17, 2017
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study

• Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors

• Patients receiving on demand replacement factors/bypassing agents therapy

Exclusion Criteria:

• Clinically relevant coagulation disorders other than congenital haemophilia A or B

• Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia A With Inhibitors
• Haemophilia B
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Other:
• No treatment given
Subject will only fill out a questionaire

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bangalore
Morocco	Novo Nordisk Investigational Site	Casablanca
Oman	Novo Nordisk Investigational Site	Muscat
South Africa	Novo Nordisk Investigational Site	Sandton

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

India,  Morocco,  Oman,  South Africa, 

References & Publications (1)

Gupta N, Belhani M, Benbouzid A, Andaloussi M El, Maani K, Mahlangu J, Wali Y, Saad HA, Fegoun SB el. The Haemocare Protocol - A composite method to measure the disease burden from Haemophilia in developing countries. European Hematology Association 2013;

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)		After 6 months (recruitment and data collection)
Primary	Clinical (using Haemophilia joint score) and radiological (using Pettersson score) orthopaedic status of defined joints: Elbow, knees and ankles in relation to haemophilia A or B		After 6 months (recruitment and data collection)
Secondary	Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores		After 6 months (recruitment and data collection)
Secondary	Usage of anti haemophilic treatment in IU/kg		During the last year preceding patient recruitment
Secondary	Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire		After 6 months (recruitment and data collection)
Secondary	Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources		After 6 months (recruitment and data collection)
Secondary	Living characteristics of the patient's household		After 6 months (recruitment and data collection)

External Links

•   Clinical Trials at Novo Nordisk