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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: Completed Phase 3 study, sponsored by Grifols Therapeutics.
NCT02604810 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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%.
Primary Outcome
The primary PK endpoint (steady-state AUC values) analysis was performed using analysis of variance (ANOVA) using PK data from a total of 49 subjects from the IV phase and 39 subjects from the SC phase.
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 |
What the finished NCT02604810 record still lists
NCT02604810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which IGIV-C 10% is the first listed.
NCT02604810 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02604810's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 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
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