Clinical trial
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK)…
NCT00460421 · Swedish Orphan Biovitrum, Industry · Completed
Key facts
| NCT number | NCT00460421 |
|---|---|
| Title | A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT |
| Official title | A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects With Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT) |
| Lead sponsor | Swedish Orphan Biovitrum, Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Leukemia |
| Intervention type | Drug, Radiation |
| Interventions | Palifermin, Total Body irradiation, Chemotherapy |
| Enrollment | 27 |
| Start date | Aug 1, 2006 |
| Primary completion | May 1, 2011 |
| Completion | May 1, 2011 |
| First posted | Apr 16, 2007 |
| Last update posted | Dec 5, 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: