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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1124-6665 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects 6 to 18 years old without inhibitors |
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| Subjects 6 to 18 years old with inhibitors |
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| Subjects above18 years old without inhibitors |
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| Subjects above 18 years old with inhibitors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | Subject will only fill out a questionaire |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores | After 6 months (recruitment and data collection) | |
| Usage of anti haemophilic treatment in IU/kg | During the last year preceding patient recruitment |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bangalore | 560001 | India | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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) |
| Casablanca |
| 20000 |
| Morocco |
| Novo Nordisk Investigational Site | Muscat | Oman |
| Novo Nordisk Investigational Site | Sandton | 2146 | South Africa |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |