Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Study Overview
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Brief Summary
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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.

Official Title
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Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Conditions
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Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects 6 to 18 years old without inhibitors<br> | Other: No treatment given<br>* Subject will only fill out a questionaire<br>|
| Subjects 6 to 18 years old with inhibitors<br> | Other: No treatment given<br>* Subject will only fill out a questionaire<br>|
| Subjects above18 years old without inhibitors<br> | Other: No treatment given<br>* Subject will only fill out a questionaire<br>|
| Subjects above 18 years old with inhibitors<br> | Other: No treatment given<br>* Subject will only fill out a questionaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores |  | After 6 months (recruitment and data collection) | 
| Usage of anti haemophilic treatment in IU/kg |  | During the last year preceding patient recruitment | 
| Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire |  | After 6 months (recruitment and data collection) | 
| Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources |  | After 6 months (recruitment and data collection) | 
| Living characteristics of the patient's household |  | After 6 months (recruitment and data collection) |