Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Number of participants wtih adverse events as a measure of safety and tolerability
研究概览
简要总结
This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.
详细描述
To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects between the ages of ≥18 years at inclusion.
- •Subjects with ileal or ileo-colic CD without fistula
- •Subjects operated or not
- •CDAI score < 220
- •no concomitant treatment excepted salicylates
- •Women of child bearing potential must be negative for pregnancy prior to study enrolment
- •contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection .
- •No tobacco consumption (end date of tobacco consumption 8 days before surgery).
- •Signed consent form
- •French social security coverage.
排除标准
- •Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
- •Subject who use of corticosteroids for 15 days before first injection of P28GST
- •Subject with history of vaccine hyper sensitivity or allergy.
- •Subject with any other clinical manifestation determined by the investigator
- •Subject wih AIDS, B or C hepatitis.
研究组 & 干预措施
P28GST treatment
P28GST as a parasite enzyme
干预措施: P28GST (Drug)
结局指标
主要结局
Number of participants wtih adverse events as a measure of safety and tolerability
时间窗: up to one year
Clinical and blood markers change from baseline
次要结局
- Main immunologic and inflammatory blood and tissue markers.(up to one year)
- Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.(up to one year)
- Intestinal microbiota(at inclusion, at 4 month , at 12 month)