Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04640142 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
A Phase 3 study of Primary Immune Deficiency, sponsored by Octapharma.
- Active
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT04640142: Active Phase 3 study of Primary Immune Deficiency, sponsored by Octapharma.
NCT04640142 is a Phase 3 study of Primary Immune Deficiency that is active but no longer recruiting, run by Octapharma. The registered enrollment target is 50 participants, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640142, a Phase 3 study of Primary Immune Deficiency, is active but no longer recruiting, sponsored by Octapharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Rate of SBIs (defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment.
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 |
What the registry record for NCT04640142 still lists
NCT04640142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,195-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (96% lower).
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.
NCT04640142 names 20 study sites across 10 states, led by Other, Florida, California.
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.
What interventions are being tested in trial NCT04640142?
The interventions under investigation include: Newnorm (BIOLOGICAL).
Who is sponsoring clinical trial NCT04640142?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Primary Immune Deficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
ACTIVE NOT RECRUITING · Phase 3
-
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
COMPLETED · Phase 3
-
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
RECRUITING
-
Biologics And Clinical Immunology Cohort at Sinai
RECRUITING
-
COVID-19 Vaccine Responses in PIDD Subjects
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI