Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries (HAEMOcare)

January 17, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560001
        • Novo Nordisk Investigational Site
  • Morocco
      • Casablanca, Morocco, 20000
        • Novo Nordisk Investigational Site
  • Oman
      • Muscat, Oman
        • Novo Nordisk Investigational Site
  • South Africa
      • Sandton, South Africa, 2146
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX activities below 1% or level below 1U dL^-1) without inhibitor or with inhibitors against FVIII or FIX

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects 6 to 18 years old without inhibitors
Other: No treatment given
Subject will only fill out a questionaire
Subjects 6 to 18 years old with inhibitors
Other: No treatment given
Subject will only fill out a questionaire
Subjects above18 years old without inhibitors
Other: No treatment given
Subject will only fill out a questionaire
Subjects above 18 years old with inhibitors
Other: No treatment given
Subject will only fill out a questionaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
Time Frame: After 6 months (recruitment and data collection)
After 6 months (recruitment and data collection)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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; Country: Sweden City: Stockholm

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 2, 2012

First Posted (ESTIMATE)

January 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAEM-3971
  • U1111-1124-6665 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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