High and low dose of IgPro20 for the maintenance treatment of CIDP
Research type
Research Study
Full title
Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003
IRAS ID
149715
Contact name
Siraj Misbah
Contact email
Sponsor organisation
CSL Behring GmbH
Eudract number
2013-004157-24
Clinicaltrials.gov Identifier
Research summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder of the part of the peripheral nervous system consisting of the nerves and ganglia. The clinical course of the disease can be relapsing/remitting or chronic and progressive as observed particularly in young adults. CIDP is believed to affect 4.7 adults per 100,000 adults and 1 child per 200,000 of the population. The current treatments available include normal human immunoglobulin for intravenous administration (IVIGs), plasma exchange and corticosteroids.Which of these treatment options is chosen for an individual patient is dependent on that patient’s disease, consideration of benefits versus risks and availability of the different options.
IgPro20 is a ready-to-use formulation of human immunoglobulin G (IgG) with ≥98% purity for subcutaneous (SC) administration. It is approved in the United States of America (US), in the European Union, in Switzerland, and in Canada under the brand name Hizentra® for primary immunodeficiency syndromes, and is manufactured at CSL Behring’s (CSLB’s) facility in Berne, Switzerland. Results from clinical studies have shown the clinical effectiveness and safety of using IVIGs to treat CIPD.
This study is an extension study to the pivotal study IgPro20_3003. It is a multicenter, open-label phase 3 study to provide further information into the long-term effectiveness and safety of treatment with IgPro20. All patients in this study will have participated in the preceding pivotal study. The study is expected to last for up to 52 weeks.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/0101
Date of REC Opinion
30 Apr 2014
REC opinion
Further Information Favourable Opinion