Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Public ClinicalTrials.gov record NCT04640142. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04640142
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Octapharma
- Industry
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- Newnorm Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 3, 2021
- Primary completion
- May 31, 2026
- Completion
- Aug 31, 2026
- Last update posted
- Jun 4, 2026
2021 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Octapharma Research Site | Irvine | California | 92697 | — |
| Octapharma Research Site | Centennial | Colorado | 80112 | — |
| Octapharma Research Site | Port Saint Lucie | Florida | 34986 | — |
| Octapharma Research Site | St. Petersburg | Florida | 33701 | — |
| Octapharma Research Site | Chicago | Illinois | 60612 | — |
| Octapharma Research Site | Overland Park | Kansas | 66211 | — |
| Octapharma Research Site | Louisville | Kentucky | 40217 | — |
| Octapharma Research Site | White Marsh | Maryland | 21162 | — |
| Octapharma Research Site | Kansas City | Missouri | 64111 | — |
| Octapharma Research Site | Omaha | Nebraska | 68046 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04640142, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2026 · Synced Jun 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04640142 live on ClinicalTrials.gov.