Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
NCT ID: NCT03276130
Last Updated: 2024-03-06
Study Results
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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COMPLETED
2300 participants
OBSERVATIONAL
2018-10-30
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Part A: Retrospective register study
To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population.
No interventions assigned to this group
Part B1: Survey to HTC
The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts.
No interventions assigned to this group
Part B2: Survey to PwH
All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;
* at least one prescription of factor VIII or factor IX concentrates, or;
* bypassing agents used in the treatment of PwH during the inclusion period.
* Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.
* Part B2 population: PwH 5 years or older listed at participating HTCs
Exclusion Criteria
5 Years
ALL
No
Sponsors
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Swedish Orphan Biovitrum
INDUSTRY
Responsible Party
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Locations
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Swedish Orphan Biovitrum Research Site
Copenhagen, , Denmark
Swedish Orphan Biovitrum Research Site
Helsinki, , Finland
Swedish Orphan Biovitrum Research Site
Gothenburg, , Sweden
Swedish Orphan Biovitrum Research Site
Malmo, , Sweden
Swedish Orphan Biovitrum Research Site
Stockholm, , Sweden
Countries
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References
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Steen Carlsson K, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Lethagen S. Comorbidity and Mortality in Men and Women With Haemophilia in Three Nordic Countries-Comparisons to Matched Controls. Haemophilia. 2025 May;31(3):401-411. doi: 10.1111/hae.70023. Epub 2025 Mar 18.
Steen Carlsson K, Winding B, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Andersson E, Lethagen S. Pain, depression and anxiety in people with haemophilia from three Nordic countries: Cross-sectional survey data from the MIND study. Haemophilia. 2022 Jul;28(4):557-567. doi: 10.1111/hae.14571. Epub 2022 Apr 23.
Other Identifiers
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Sobi.HAEM89-003
Identifier Type: -
Identifier Source: org_study_id
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