Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02269163 · ClinicalTrials.gov registry record · Phase 3
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
A Phase 3 study, sponsored by Prometic Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 82
- Enrollment target
NCT02269163: Completed Phase 3 study, sponsored by Prometic Biotherapeutics.
NCT02269163 is a Phase 3 study that has completed, run by Prometic Biotherapeutics. The registered enrollment target is 82 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02269163, a Phase 3 study, has completed, sponsored by Prometic Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 82 participants
- Enrollment target
Study Summary
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
Primary Outcome
SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negati
Interventions
- BIOLOGICAL Immune Globulin Intravenous
- BIOLOGICAL Prometic's Immune Globulin Intravenous 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2016-01-26 |
| Est. Completion | 2019-01-11 |
| Phase | Phase 3 |
What the finished NCT02269163 record still lists
NCT02269163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Immune Globulin Intravenous is the first listed.
NCT02269163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02269163 about?
NCT02269163 is a clinical study titled "Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%". Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
What is the current status of trial NCT02269163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2016-01-26. Estimated completion is 2019-01-11.
What interventions are being tested in trial NCT02269163?
The interventions under investigation include: Immune Globulin Intravenous (BIOLOGICAL), Prometic's Immune Globulin Intravenous 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT02269163?
This trial is sponsored by Prometic Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02269163's enrollment target sits among peer trials
82 1752nd of 2000 higher than 249 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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
- NCT03319901 · 82 participants · Phase 1
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
- NCT03493425 · 82 participants · Phase 2
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
- NCT04105270 · 82 participants · Phase 2
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
- NCT04428658 · 82 participants · NA
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
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