Status:
COMPLETED
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Hematologic Diseases
Secondary Immune Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusi...
Detailed Description
Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without ...
Eligibility Criteria
Inclusion
- Age =\> 18 years
- Immunodeficiency secondary to a hematologic disorder
- Patient has received at least 2 Multigam IV 5% administrations
- Patient may not have had any adverse events (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
- Patient needs at least 2 more immunoglobulin administrations
- Signed informed consent
Exclusion
- Patient has received less than 2 Multigam IV 5% administrations
- Patient has had an adverse event (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
- Refusal to sign informed consent
Key Trial Info
Start Date :
June 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 13 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03250845
Start Date
June 30 2017
End Date
December 13 2017
Last Update
November 15 2019
Active Locations (1)
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1
UZ Leuven Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000