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
Latest Information Update: 11 Jun 2025
At a glance
- Drugs Immune globulin (Primary)
- Indications Bacterial infections; Primary immunodeficiency diseases
- Focus Registrational; Therapeutic Use
- Sponsors Octapharma
Most Recent Events
- 05 Jun 2025 Planned End Date changed from 1 Jun 2025 to 1 Sep 2026.
- 03 Jan 2024 Planned End Date changed from 1 Mar 2025 to 1 Jun 2025.
- 03 Jan 2024 Planned primary completion date changed from 1 Mar 2025 to 1 Jun 2025.