The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
• 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.
Locations
United States
New Jersey
Rutgers, The State University of New Jersey Clinical Research Center
RECRUITING
New Brunswick
Contact Information
Primary
Luigi Brunetti, PhD
brunetti@pharmacy.rutgers.edu
2016385868
Time Frame
Start Date: 2022-09-11
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 20
Treatments
Experimental: Intravenous immune globulin G
Subjects will receive there current intravenous immune globulin dose.
Experimental: Subcutaneous immune globulin G
The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey