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A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

NCT00323518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2016-04-13

No results posted yet for this study

Summary

CG53135-05 (velafermin), 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 confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.

Conditions

Interventions

DRUG

velafermin

administered intravenously as 100mL single dose over 15 minutes on day 1

DRUG

placebo

administered intravenously as 100mL single dose over 15 minutes on day 1

Sponsors & Collaborators

  • CuraGen Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323518 on ClinicalTrials.gov