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NCT00323518 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by CuraGen Corporation.

Completed
Registry status
Phase 2
Development phase
390
Enrollment target

NCT00323518: Completed Phase 2 study, sponsored by CuraGen Corporation.

NCT00323518 is a Phase 2 study that has completed, run by CuraGen Corporation. The registered enrollment target is 390 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00323518, a Phase 2 study, has completed, sponsored by CuraGen Corporation.

COMPLETED
Registry status
Phase 2
Development phase
390 participants
Enrollment target

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.

Interventions

  • DRUG placebo
  • DRUG velafermin

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2006-05
Est. Completion 2008-08
Phase Phase 2
CuraGen Corporation

4 total trials

What the finished NCT00323518 record still lists

NCT00323518 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00323518 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00323518 about?

NCT00323518 is a clinical study titled "A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis". 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....

What is the current status of trial NCT00323518?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2006-05. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00323518?

The interventions under investigation include: placebo (DRUG), velafermin (DRUG).

Who is sponsoring clinical trial NCT00323518?

This trial is sponsored by CuraGen Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00323518's enrollment target sits among peer trials

390 106th of 2000 higher than 1,893 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00323518, the US trial registry maintained by the National Library of Medicine. NCT00323518 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.