drugset / Trial / NCT04898309

Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

NCT04898309

Phase 2/3 Withdrawn AO GENERIUM
RandomizedParallel-groupDouble-blindTreatment

Summary

It is a placebo-controlled randomized trial to evaluate the efficacy and safety of GNR-038 in comparison with Berinert® in patients with hereditary angioedema

Timeline

Start
2021-12-01
Primary completion
2023-05-31
Completion
2023-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 20 iu/kg Intravenous
Subject GNR-038 Protein / enzyme biologic 50 iu/kg Intravenous
Subject GNR-038 Protein / enzyme biologic 100 iu/kg Intravenous

Indications