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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01503567 |
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Date of registration:
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02/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
HAEMOcare |
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Scientific title:
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Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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282 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01503567 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Algeria
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India
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Morocco
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Oman
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South Africa
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion 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
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Congenital Bleeding Disorder
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Haemophilia B With Inhibitors
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Haemophilia A
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Haemophilia A With Inhibitors
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Haemophilia B
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Intervention(s)
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Other: No treatment given
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Primary Outcome(s)
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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)]
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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)]
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Secondary Outcome(s)
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Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores
[Time Frame: After 6 months (recruitment and data collection)]
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Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire
[Time Frame: After 6 months (recruitment and data collection)]
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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)]
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Living characteristics of the patient's household
[Time Frame: After 6 months (recruitment and data collection)]
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Usage of anti haemophilic treatment in IU/kg
[Time Frame: During the last year preceding patient recruitment]
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Secondary ID(s)
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HAEM-3971
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U1111-1124-6665
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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