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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.
Details
| Lead sponsor | CuraGen Corporation |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Start date | 2005-01 |
| Completion | 2005-12 |
Conditions
- Stomatitis
Interventions
- CG53135-05, velafermin
Countries
United States