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NCT04566692 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
A Phase 4 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT04566692: Completed Phase 4 study, sponsored by Grifols Therapeutics.
NCT04566692 is a Phase 4 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566692, a Phase 4 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).
Primary Outcome
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participa
Interventions
- BIOLOGICAL IGSC 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2022-07-25 |
| Phase | Phase 4 |
What the finished NCT04566692 record still lists
NCT04566692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which IGSC 20% is the first listed.
NCT04566692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04566692 about?
NCT04566692 is a clinical study titled "A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency". The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-...
What is the current status of trial NCT04566692?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2020-11-24. Estimated completion is 2022-07-25.
What interventions are being tested in trial NCT04566692?
The interventions under investigation include: IGSC 20% (BIOLOGICAL).
Who is sponsoring clinical trial NCT04566692?
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 NCT04566692's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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