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Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
NCT04640142 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BIOLOGICAL Newnorm
Study Locations (20)
Other
- Octapharma Research Site — Leipzig
- Octapharma Research Site — Munich
- Octapharma Research Site — Budapest
- Octapharma Research Site — Debrecen
- Octapharma Research Site — Naples
- Octapharma Research Site — Roma
- Octapharma Research Site — Roma
- Octapharma Research Site — Treviso
- Octapharma Research Site — Krakow
Florida
- Octapharma Research Site — Hollywood
- Octapharma Research Site — Port Saint Lucie
- Octapharma Research Site — St. Petersburg
California
- Octapharma Research Site — Irvine
Colorado
- Octapharma Research Site — Centennial
Illinois
- Octapharma Research Site — Chicago
Kansas
- Octapharma Research Site — Overland Park
Kentucky
- Octapharma Research Site — Louisville
Maryland
- Octapharma Research Site — White Marsh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04640142
The ClinicalTrials.gov registry entry for NCT04640142 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Immune Deficiency appearing as the primary indexed condition, and to 1 intervention — of which Newnorm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04640142 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04640142 about?
NCT04640142 is a clinical study titled "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
What is the current status of trial NCT04640142?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2021-08-04. Estimated completion is 2026-09.
What conditions does trial NCT04640142 study?
This clinical trial studies the following conditions: Primary Immune Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04640142?
The interventions under investigation include: Newnorm (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04640142?
This trial is sponsored by Octapharma, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04640142 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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