A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Soligenix
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
研究概览
简要总结
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
- •Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
- •Endoscopic findings consistent with GI GVHD
- •Must be able to swallow tablets
- •Must be able to read and understand informed consent
- •Adequate birth control methods for the duration of the study
排除标准
- •>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
- •GI infection
- •Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- •HIV seropositivity
- •Pregnant or nursing female
- •Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
- •Evidence of recurrent or progressing malignant disorder that was the indication for HCT
研究组 & 干预措施
Placebo
Control
干预措施: Placebo (Drug)
orBec
Investigational drug
干预措施: orBec (Drug)
结局指标
主要结局
Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
时间窗: 16 weeks
Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue. GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of ≥ 3. A CR will be defined as a composite score of 0.
次要结局
未报告次要终点