A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
Public ClinicalTrials.gov record NCT00323518. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00323518
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 390 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2006 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Aug 2008 (Actual)
- Last update posted
- Apr 13, 2016
2006 – 2008
United States locations
- U.S. sites
- 33
- U.S. states
- 22
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Alta Bates Comprehensive Cancer Center | Berkley | California | 94704 | — |
| Research Facility | La Jolla | California | 92037 | — |
| Scripps Green Medical Center | La Jolla | California | 92037 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado | 80218 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| St. Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Louisiana State University Health Science Center | Shreveport | Louisiana | 71130 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| MAYO Clinic | Rochester | Minnesota | 55905 | — |
| Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Cornell Medical Center | New York | New York | 10021 | — |
| Biomedical Research Alliance of New York | New York | New York | 10029 | — |
| Biomedical Research Alliance of New York | The Bronx | New York | 10467 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Good Samaritan Hospital and Cancer Center | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Fox Chase-Temple Bone Marrow Transplant Program | Philadelphia | Pennsylvania | 19111 | — |
| Roger Williams Medical Center | Providence | Rhode Island | 02908 | — |
| Medical University of South Carolina Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| University of Texas Health Science Center | San Antonio | Texas | 78229-3900 | — |
| Medical College of Wisonsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00323518, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2016 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00323518 live on ClinicalTrials.gov.