drugset
drugset / Trial / NCT04640142

Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

NCT04640142 ↗

Phase 3 Active not recruiting 50 enrolled Octapharma
NaSingle-groupOpen-labelTreatment

Summary

Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases

Timeline

Start
2021-08-04
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 20 % Subcutaneous

Indications

immunodeficiency disease