NCT00104065已完成2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 10
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ages > 18 yrs
- •Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
- •Patients with Karnofsky performance scores > or = 70%
- •Informed consent for participation in study
排除标准
- •Patients who weigh < 33 kg
- •Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
- •Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
- •Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
- •Patients with known hypersensitivity to recombinant protein therapeutics
- •Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days
- •Patients who have untreated symptomatic dental infection
- •Patients with a history of sensitivity or allergy to E. coli-derived products
- •Patients with WHO Grade 3 or 4 oral mucositis (OM)
研究者
研究点 (10)
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