drugset / Trial / NCT02796937

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

NCT02796937

Phase 3 Enrolling by invitation 290 enrolled Grifols Therapeutics LLC
NaSingle-groupOpen-labelTreatment

Summary

This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

Timeline

Start
2016-07
Primary completion
2028-09
Completion
2029-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 60 mg/kg Intravenous

Indications