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Completed

NCT Number: NCT01503567

Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

6 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bangalore, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Subject will only fill out a questionaire

Primary outcomes

  1. Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)

    Time frame: After 6 months (recruitment and data collection)

  2. 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

    Time frame: After 6 months (recruitment and data collection)

Secondary outcomes

  1. Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores

    Time frame: After 6 months (recruitment and data collection)

  2. Usage of anti haemophilic treatment in IU/kg

    Time frame: During the last year preceding patient recruitment

  3. Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire

    Time frame: After 6 months (recruitment and data collection)

  4. Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources

    Time frame: After 6 months (recruitment and data collection)

  5. Living characteristics of the patient's household

    Time frame: After 6 months (recruitment and data collection)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: HAEMOcare

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 4, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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