Trials / Active Not Recruiting
Active Not RecruitingNCT04640142
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Newnorm | Newnorm is a 20% human normal immunoglobulin for SC infusion. |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2026-06-01
- Completion
- 2026-09-01
- First posted
- 2020-11-23
- Last updated
- 2025-10-03
Locations
24 sites across 7 countries: United States, Germany, Hungary, Italy, Poland, Slovakia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04640142. Inclusion in this directory is not an endorsement.