Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2019

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions
Primary Immunodeficiency
Interventions
BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

Trial Locations (4)

15241

Allergy & Clinical Immunology Associates, Pittsburgh

43235

Optimed Research LTD, Columbus

46617

The South Bend Clinic LLP, South Bend

73131

Oklahoma Institute of Allergy and Asthma Clinical Research, Oklahoma City

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY

NCT03814798 - Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency | Biotech Hunter | Biotech Hunter