NCT01255696已完成2 期
A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Efficacy: Intestinal mucosal morphology
研究概览
简要总结
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of biopsy-proven celiac disease
- •Adherence to a gluten-free diet
- •TG2 antibody negative
- •Signed informed consent
排除标准
- •Active dermatitis herpetiformis
- •History of IgE-mediated reactions to gluten
- •Use of specific medications 6 months prior to entry
- •History of alcohol abuse or illicit drug use
- •Current untreated or GI disease
- •Positive pregnancy test
- •Received any experimental drug within 14 days of randomization
- •Uncontrolled chronic disease or condition
- •Uncontrolled complications of celiac disease
- •Any medical condition which could adversely affect study participation
研究组 & 干预措施
Placebo
Placebo Comparator
Excipients for ALV003 absent the experimental compounds
干预措施: ALV003 placebo (Biological)
ALV003
Experimental
ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.
干预措施: ALV003 (Biological)
结局指标
主要结局
Efficacy: Intestinal mucosal morphology
时间窗: 6 weeks
Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003
时间窗: 6 weeks
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts
次要结局
- Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype(6 weeks)
- Efficacy: Change in serological markers of celiac disease(6 weeks)
研究者
研究点 (3)
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