Drugs / IgPro10

Trials 6

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT04138485 Dec 2019 → Sep 2020 diffuse cutaneous systemic sclerosis CSL Behring Withdrawn No outcome recorded Stop: Business
Phase 2 NCT04137224 Sep 2019 → May 2022 diffuse cutaneous systemic sclerosis CSL Behring Completed No outcome recorded
Phase 32 trials
Phase 3 NCT00322556 Nov 2005 → Apr 2008 common variable immunodeficiency, selective IgG immunodeficiency CSL Behring Completed No outcome recorded
Phase 3 NCT00168025 Sep 2004 → Mar 2006 common variable immunodeficiency, selective IgG immunodeficiency CSL Behring Completed No outcome recorded
Phase 42 trials
Phase 4 NCT03684018 Feb 2019 → Dec 2029 expected chronic inflammatory demyelinating polyradiculoneuropathy CSL Behring Recruiting No outcome recorded
Phase 4 NCT01390649 Nov 2011 → Sep 2014 autoimmune thrombocytopenic purpura CSL Behring Completed No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT01545076 Background Mar 2012 → Sep 2016 polyneuropathy, inflammatory demyelinating, chronic, polyradiculoneuropathy CSL Behring Completed Met primary

Press releases naming this drug 11 releases

DateIssuerRelease
2020-02-11 CSL Behring PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) Granted Orphan-Drug Designation for the Investigational Treatment of Systemic Sclerosis (SSc) csl.com ↗
2017-09-14 CSL Behring CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults csl.com ↗
2017-02-14 CSL Behring FDA Accepts CSL Behring’s Biologics License Application Supplement for Using Privigen® to Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a Rare Neurological Condition csl.com ↗
2016-02-24 CSL Behring CSL Behring Adds Isoagglutinin Reduction Step to Privigen® Manufacturing Process csl.com ↗
2016-02-23 CSL Behring First Export of Privigen® From New Manufacturing Facility in Broadmeadows, Melbourne, Australia csl.com ↗
2013-04-04 CSL Behring European Commission Grants Marketing Authorization to CSL Behring’s Privigen® in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2013-02-21 CSL Behring CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura csl.com ↗
2012-06-27 CSL Behring PRIMA Study Shows Treatment with Privigen® Improved Function in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2012-05-31 CSL Behring CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) csl.com ↗
2010-10-07 CSL Behring Privigen Demonstrates Efficacy and Tolerability Among Patients With Various Immunodeficiencies, Data Show csl.com ↗
2010-04-19 CSL Behring CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 Months csl.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as IgPro10 “A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)” NCT00168025 ↗
6

“Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)” NCT00322556 ↗

NCT03684018 ↗

NCT01390649 ↗

NCT04138485 ↗

NCT01545076 ↗

NCT04137224 ↗

Known as Privigen “10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue...” NCT01545076 ↗
1

“IgPro10 (Intravenous Immunoglobulin, Privigen®)” NCT04137224 ↗

Modality Protein / enzyme biologic “a novel, 10% liquid formulation of intravenous immunoglobulin” PMID 18814020 ↗ Sep 2008
Route Intravenous “for intravenous administration” PMID 20217199 ↗ Mar 2010