Clinical trial
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin…
NCT00295061 · Grifols Therapeutics LLC, Industry · Completed
Key facts
| NCT number | NCT00295061 |
|---|---|
| Title | Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults |
| Official title | Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency. |
| Acronym | ChAMP |
| Lead sponsor | Grifols Therapeutics LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Alpha 1-Antitrypsin Deficiency |
| Intervention type | Drug |
| Interventions | Alpha-1 MP, alpha-1 proteinase inhibitor (human) |
| Enrollment | 24 |
| Start date | May 1, 2006 |
| Primary completion | Feb 1, 2007 |
| Completion | Feb 1, 2007 |
| First posted | Feb 22, 2006 |
| Last update posted | Sep 9, 2014 |
| Countries | 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: