A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial.
The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG
in patients with worsening MG.
Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are
considered to be appropriate for immunoglobulin therapy will be screened for the study by the
treating neurologist.
Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused
over 4 weeks in a dose escalating manner.
Additionally, this study will be assessing the feasibility of employing SCIG as an
alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG
versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a
health-resource perspective and from a patient perspective.
Phase:
Phase 3
Details
Lead Sponsor:
University of Alberta
Collaborator:
CSL Behring
Treatments:
Antibodies Immunoglobulin G Immunoglobulins Immunoglobulins, Intravenous