Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

Phase 3 Completed 49 enrolled Green Cross Corporation Atlantic Research Group · collab Parexel · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).

Timeline

Start: 2016-10
Primary completion: 2019-07
Completion: 2019-07

Outcome

Met primary endpoint

paper upper 99% one-sided confidence interval limit: 0.21), meeting the prespecified primary efficacy endpoint. PMID 34305948 ↗

paper upper 95% one-sided confidence interval limit: 0.31), meeting the pre-specified primary safety endpoint. PMID 34305948 ↗

Publications

Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC5107	Protein / enzyme biologic	300 mg/kg	Intravenous
Subject	GC5107	Protein / enzyme biologic	900 mg/kg	Intravenous