N/A
N=30
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder
Hematologic Diseases · Secondary Immune Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT03250845 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Infusion Time of Multigam IV 5% and Multigam IV 10% — 4.92; 2.29 hour — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infusion Time of Multigam IV 5% and Multigam IV 10% |
4.92; 2.29 | <0.0001 sig |
| SECONDARY Hospitalisation Time of Multigam IV 5% and Multigam IV 10% |
5.87; 4.56 | <0.0005 sig |
| SECONDARY IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration |
0; 0.43 | — |
| SECONDARY Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration |
1.03; 0.67 | 0.03 sig |
| SECONDARY Patient Satisfaction Questionnaire. |
3; 5; 4; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03250845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.