NCT00859391已完成不适用
A Phase 0 Study in Subjects With Well Controlled Celiac Disease to Assess the Effects of Gluten Digestion With ALV003 (a Protease Enzyme) in Vitro
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The clinical response by symptom measurement before and after oral challenge
研究概览
简要总结
This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.
详细描述
The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo:
- The clinical response by symptom measurement before and after oral challenge
- The immune response measured by ELISPOT testing and serology The secondary objective of the study is to
- Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Well controlled Celiac Disease without flare in symptoms for the past 8 weeks
- •History of biopsy proven Celiac Disease
- •Able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge
- •Been on a gluten free diet for 8 weeks prior to study entry
- •Have normal celiac serology (anti- tTG level of <20 units/mL)
排除标准
- •Uncontrolled complications of celiac disease which in the opinion of the Investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease)
- •Pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception
- •Concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, NSAIDs. Chronic medications for well-controlled chronic conditions are allowed.
- •Clinically significant abnormal lab values, as determined by the PI:
- •Untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases.
- •Positive pregnancy test within 7 days prior to study drug administration
- •Known allergy or hypersensitivity to E.coli or E.coli derived proteins
结局指标
主要结局
The clinical response by symptom measurement before and after oral challenge
时间窗: Day 1 and Day 6
The immune response measured by ELISPOT testing and celiac disease serology
时间窗: Prior to and post 3-day gluten challenge
次要结局
- Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo(Day 1 and Day 14)
研究者
研究点 (1)
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