Clinical trial NCT03250845: Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder
Official title: Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Secondary Immune Deficiency
Keywords: Multigam
Immunoglobulin
Secondary immunodeficiency
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients with an immunodeficiency secondary to a hematologic disorder

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 infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.

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 loss of quality in care.

In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.

For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Infusion Time of Multigam IV 5% and Multigam IV 10%
timeFrame: Up to 1 month after Multigam 5% infusion
Secondary outcomes:
measure: Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
timeFrame: Up to 1 month after Multigam 5% infusion
measure: IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration
timeFrame: Up to 72 after each infusion
measure: Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
timeFrame: During each infusion (up to 1 day)
measure: Patient Satisfaction Questionnaire.
timeFrame: End of study (after Multigam 10% infusion)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven Gasthuisberg
name: Michel Delforge, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: