Hizentra 200 mg/ml solution for subcutaneous injection
Sponsors
CSL Behring LLC, Universitair Medisch Centrum Utrecht, Region Midtjylland
Conditions
Chronic inflammatory demyelinating polyneuropathy (CIDP)DermatomyositisPost-COVID-19 Postural Orthostatic Tachycardia SyndromePrimary antibody deficiency:
- Unclassified antibody deficiency (unPAD)
- IgA deficiency
- Specific polysaccharide antibody deficiency (SPAD)
- IgG subclass deficiency (IgSD)
- Common variable immunodeficiency (CVID)
- Agammaglobulinemia (X-linked or otherwise)Secondary Immune Deficiency
Phase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study
CompletedCTIS2023-508293-28-00
Start: 2020-02-20End: 2024-10-21Target: 66Updated: 2024-10-24
Influencing Progression of Airway Disease in Primary Antibody Deficiency
Not yet recruitingCTIS2024-513124-41-00
Target: 100Updated: 2024-07-12
Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy
Not yet recruitingCTIS2024-515898-96-01
Target: 60Updated: 2024-10-15
Double-blind, Randomized, Placebo-controlled Phase 3 study Evaluating Efficacy and Safety of IgPro20 (subcutaneous immunoglobulin, HIZENTRA®) in post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
CompletedCTIS2023-508744-22-00
End: 2025-05-13Target: 17Updated: 2025-05-08
A Phase 3, Prospective, Open-label, Multicenter, Single-arm Study to Investigate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Subjects with Secondary Immune Deficiency due to Hematologic Malignancies Treated with B-cell Targeting Chimeric Antigen Receptor T-Cell and T-Cell Redirecting Therapies
Not yet recruitingCTIS2026-525626-38-00
Target: 21Updated: 2026-10-20