Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

NCT ID: NCT01503567

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects 6 to 18 years old without inhibitors

No treatment given

Intervention Type OTHER

Subject will only fill out a questionaire

Subjects 6 to 18 years old with inhibitors

No treatment given

Intervention Type OTHER

Subject will only fill out a questionaire

Subjects above18 years old without inhibitors

No treatment given

Intervention Type OTHER

Subject will only fill out a questionaire

Subjects above 18 years old with inhibitors

No treatment given

Intervention Type OTHER

Subject will only fill out a questionaire

Interventions

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No treatment given

Subject will only fill out a questionaire

Intervention Type OTHER

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Novo Nordisk Investigational Site

Casablanca, , Morocco

Site Status

Novo Nordisk Investigational Site

Muscat, , Oman

Site Status

Novo Nordisk Investigational Site

Sandton, , South Africa

Site Status

Countries

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India Morocco Oman South Africa

References

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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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1124-6665

Identifier Type: OTHER

Identifier Source: secondary_id

HAEM-3971

Identifier Type: -

Identifier Source: org_study_id

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