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NCT00389324 · ClinicalTrials.gov registry record · Phase 2
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00389324: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT00389324 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00389324, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.
Primary Outcome
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
Interventions
- BIOLOGICAL Immune Globulin Intravenous (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
What the finished NCT00389324 record still lists
NCT00389324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Immune Globulin Intravenous (Human) is the first listed.
NCT00389324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00389324 about?
NCT00389324 is a clinical study titled "A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency". This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.
What is the current status of trial NCT00389324?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2006-11. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00389324?
The interventions under investigation include: Immune Globulin Intravenous (Human) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00389324?
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 NCT00389324's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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