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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01503567
First received: January 2, 2012
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Congenital Bleeding Disorder
Haemophilia A
Haemophilia A With Inhibitors
Haemophilia B
Haemophilia B With Inhibitors
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores [ Time Frame: After 6 months (recruitment and data collection) ] [ Designated as safety issue: No ]
  • Usage of anti haemophilic treatment in IU/kg [ Time Frame: During the last year preceding patient recruitment ] [ Designated as safety issue: No ]
  • Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire [ Time Frame: After 6 months (recruitment and data collection) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Living characteristics of the patient's household [ Time Frame: After 6 months (recruitment and data collection) ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503567

Locations
Algeria
Algiers, Algeria, 16035
India
Bangalore, India, 560001
Morocco
Casablanca, Morocco, 20000
Oman
Muscat, Oman
South Africa
Sandton, South Africa, 2146
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01503567     History of Changes
Other Study ID Numbers: HAEM-3971, U1111-1124-6665
Study First Received: January 2, 2012
Last Updated: November 13, 2014
Health Authority: Algeria: Ministry of Health
India: Ministry of Health and Family Wellfare
Morocco: Direction Drugs & Pharmacy (DMP)
Oman: Ministry of Health
South Africa: Medicines Control Council

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014