Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Completed

• Conditions: Haemophilia A; Haemophilia B With Inhibitors; Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B
• Interventions: Other: No treatment given

• Registration Number: NCT01503567
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 282

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects 6 to 18 years old without inhibitors	No treatment given	-
Subjects 6 to 18 years old with inhibitors	No treatment given	-
Subjects above 18 years old with inhibitors	No treatment given	-
Subjects above18 years old without inhibitors	No treatment given	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Usage of anti haemophilic treatment in IU/kg	During the last year preceding patient recruitment
Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores	After 6 months (recruitment and data collection)
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇿🇦 Sandton, South Africa