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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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26 September 2023 |
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Main ID: |
NCT03054181 |
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Date of registration:
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13/02/2017 |
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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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Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO)
FIGARO |
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Scientific title:
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Facilitated Immunoglobulin Administration Registry and Outcomes Study |
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Date of first enrolment:
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December 22, 2016 |
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Target sample size:
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156 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03054181 |
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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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Countries of recruitment
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France
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Germany
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Italy
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Contacts
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Name:
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Nizar Mahlaoui, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Paris, France |
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Name:
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Leif Hanitsch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charité Berlin, Germany |
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Name:
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Michael Borte, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg Leipzig |
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Name:
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David Pittrow, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GWT-TUD GmbH, Dresden, Germany |
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Name:
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Isabelle Quinti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sapienza University Rome, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient has received/will receive at least 1 HyQvia infusion for PID or SID
- Patient has an indication for chronic immunoglobulin treatment
- Patient is likely available for long-term documentation
- Patient provides informed consent for documentation
Exclusion Criteria:
- No explicit exclusion criteria apply.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Secondary Immune Deficiency
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Primary Immunodeficiency
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Intervention(s)
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Biological: HyQvia
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Primary Outcome(s)
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Utilisation in terms of dose and dosing interval
[Time Frame: up to 3 years]
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Secondary Outcome(s)
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Adverse events
[Time Frame: up to 3 years]
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Number of participants with treatment-related adverse events
[Time Frame: up to 3 years]
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Number of training session
[Time Frame: up to 3 years]
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Concomitant diseases
[Time Frame: up to 3 years]
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mean immunoglobulin trough level
[Time Frame: up to 3 years]
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Number of days in hospital
[Time Frame: up to 3 years]
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Number of days in rehabilitation clinic
[Time Frame: up to 3 years]
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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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