Trials / Completed
CompletedNCT00104065
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- CuraGen Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CG53135-05, velafermin |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2005-12-01
- Completion
- 2005-12-01
- First posted
- 2005-02-23
- Last updated
- 2016-03-15
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00104065. Inclusion in this directory is not an endorsement.