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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 is a Phase 3 study that has completed, run by Prometic Biotherapeutics. The registered enrollment target is 82 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02269163
The ClinicalTrials.gov registry entry for NCT02269163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prometic Biotherapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Immune Globulin Intravenous is the first listed.
NCT02269163 reports 0 study locations.
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.
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