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NCT02604810 · ClinicalTrials.gov registry record · Phase 3
Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT02604810 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 53 participants.
The verdict
NCT02604810, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.
Interventions
- BIOLOGICAL IGIV-C 10%
- BIOLOGICAL IGSC 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02604810
The ClinicalTrials.gov registry entry for NCT02604810 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IGIV-C 10% is the first listed.
NCT02604810 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02604810 about?
NCT02604810 is a clinical study titled "Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency". This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose ...
What is the current status of trial NCT02604810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2016-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02604810?
The interventions under investigation include: IGIV-C 10% (BIOLOGICAL), IGSC 20% (BIOLOGICAL).
Who is sponsoring clinical trial NCT02604810?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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