Status:
COMPLETED
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
18+ years
Brief Summary
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
Eligibility Criteria
Inclusion
- Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate
- Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months
- The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study
- Providing informed consent before the start of any study-related activities
Exclusion
- Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02241694
Start Date
November 1 2014
End Date
July 1 2015
Last Update
July 10 2015
Active Locations (1)
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1
Säo Paulo, Brazil, 05001-400