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NCT01465958 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
A Phase 4 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01465958 is a Phase 4 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT01465958, a Phase 4 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age with Primary Immunodeficiency.
Interventions
- BIOLOGICAL GAMUNEX-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01465958
The ClinicalTrials.gov registry entry for NCT01465958 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 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 GAMUNEX-C is the first listed.
NCT01465958 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01465958 about?
NCT01465958 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency". The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age with Primary Immunodeficiency.
What is the current status of trial NCT01465958?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2011-11. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01465958?
The interventions under investigation include: GAMUNEX-C (BIOLOGICAL).
Who is sponsoring clinical trial NCT01465958?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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