Start Date
December 31, 2019
Primary Completion Date
September 30, 2020
Study Completion Date
September 30, 2020
IGSC 20% daily push versus every 2 weeks pump
IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence
IGSC 20% daily push versus once a week pump
IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence
IGSC 20% daily push versus 2 times per week pump
IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence
IGSC 20% 150 mg/kg
loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump
Allergy & Clinical Immunology Associates, Pittsburgh
Optimed Research LTD, Columbus
The South Bend Clinic LLP, South Bend
Oklahoma Institute of Allergy and Asthma Clinical Research, Oklahoma City
Lead Sponsor
Grifols Therapeutics LLC
INDUSTRY