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Search / Trial NCT03250845

Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Aug 11, 2017

Trial Information

Current as of April 29, 2025

Completed

Keywords

Multigam Immunoglobulin Secondary Immunodeficiency

ClinConnect Summary

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...

Gender

ALL

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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Michel Delforge, MD PhD

Principal Investigator

UZ Leuven Gasthuisberg

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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