Clinical trial
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous…
NCT00389324 · Grifols Therapeutics LLC, Industry · Completed
Key facts
| NCT number | NCT00389324 |
|---|---|
| Title | A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency |
| Official title | An Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics and Safety of Subcutaneous Gamunex® 10% (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) in Subjects With Primary Immunodeficiency |
| Lead sponsor | Grifols Therapeutics LLC, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Immunologic Deficiency Syndrome |
| Intervention type | Biological |
| Interventions | Immune Globulin Intravenous (Human) |
| Enrollment | 35 |
| Start date | Nov 1, 2006 |
| Primary completion | Aug 1, 2008 |
| Completion | Aug 1, 2008 |
| First posted | Oct 18, 2006 |
| Last update posted | Apr 20, 2015 |
| Countries | Canada, United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: