Study of immune deficiency patients treated with subcutaneous immunoglobulin (IgPro20, Hizentra®) on weekly and biweekly schedules

• Conditions: Primary Immune DeficiencySecondary Immune Deficiency; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-004977-34-Outside-EU/EEA
• Lead Sponsor: CSL Behring, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Full study:
• Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy.

Pharmacokinetic substudy:
• Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy.
• Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study.
• Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject.
• Women of childbearing potential with a positive pregnancy test.
• Active infection at the time of screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified