Efficacy, PK, Safety and Tolerability of IGSC 20% in Subjects with PI
Research type
Research Study
Full title
A Multi-Center, Open-Label, Single-Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency
IRAS ID
188274
Contact name
Claire Bethune
Contact email
Sponsor organisation
Grifols Therapeutics Inc.
Eudract number
2015-003290-15
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
An investigation is being conducted to look into how safe and effective the study drug, IGSC 20% in subjects with Primary Immunodeficiency. Approximately 60 subjects will be enrolled so that approximately 20 adult subjects and 20 pediatric subjects are treated and complete the study. This study will include 3 study stages: Screening/Previous Regimen Phase, where subjects will be continue with their current IV or SC regimen; Treatment Stage 1, where subjects will receive 13 IGSC 20% doses weekly; and Treatment Stage 2 where subjects will receive 39 IGSC 20% doses weekly.\nA total of 52 doses of IGSC 20% will be administered with a final follow-up visit 1 week after the last dose at Week 53.
REC name
Wales REC 3
REC reference
16/WA/0046
Date of REC Opinion
12 May 2016
REC opinion
Further Information Favourable Opinion