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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 is a Phase 4 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 33 participants.

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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).

Interventions

  • BIOLOGICAL IGSC 20%

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2020-11-24
Est. Completion 2022-07-25
Phase Phase 4

Sponsor

Grifols Therapeutics

34 total trials

What the Registry Record Tells You About NCT04566692

The ClinicalTrials.gov registry entry for NCT04566692 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 33 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 1 intervention - of which IGSC 20% is the first listed.

NCT04566692 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.