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NCT04561115 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT04561115 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 33 participants.
The verdict
NCT04561115, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined dosing interval (\[AUC0-τ\] either every 3 weeks \[AUC0-21 days\] or every 4 weeks \[AUC0-28 days\]) and maximum concentration in a dosing interval (Cmax) in participants diagnosed with primary humoral immunodeficiency (PI) currently receiving chronic IVIG replacement treatment.
Interventions
- BIOLOGICAL Gamunex-C
- BIOLOGICAL IVIG-PEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04561115
The ClinicalTrials.gov registry entry for NCT04561115 describes a study currently listed as completed, categorized as Phase 3. 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 2 interventions - of which Gamunex-C is the first listed.
NCT04561115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04561115 about?
NCT04561115 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency". The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined dosing interval (\[AUC0-τ\] either every 3 weeks \[AUC0-21 days\] or every...
What is the current status of trial NCT04561115?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2020-09-02. Estimated completion is 2022-03-28.
What interventions are being tested in trial NCT04561115?
The interventions under investigation include: Gamunex-C (BIOLOGICAL), IVIG-PEG (BIOLOGICAL).
Who is sponsoring clinical trial NCT04561115?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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