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

NCT03250845 | Completed Results DMC

• 1 other identifier: HEM-2017-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases; Secondary Immune Deficiency

Keywords

Multigam; Immunoglobulin; Secondary immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Infusion Time of Multigam IV 5% and Multigam IV 10%

  Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.

  Up to 1 month after Multigam 5% infusion

Secondary Outcomes (4)

• Hospitalisation Time of Multigam IV 5% and Multigam IV 10%

  Up to 1 month after Multigam 5% infusion

• IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration

  Up to 72 after each infusion

• Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration

  During each infusion (up to 1 day)

• Patient Satisfaction Questionnaire.

  End of study (after Multigam 10% infusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

30 patients with an immunodeficiency secondary to a hematologic disorder

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Datamanager
• Organization: UZ Leuven

jonas.vanham@uzleuven.be

+3216346880

Study Officials

• Michel Delforge, MD PhD

  UZ Leuven Gasthuisberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 16, 2017
• Study Start: June 30, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 13, 2017
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-10

Locations

BE (1)