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
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
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)
Loading locations...
相似试验
招募中
2 期
Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19 (BRIGHT Study)COVID-19NCT05445934Frontier Biotechnologies Inc.1,188
终止
2 期
Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)Facioscapulohumeral Muscular DystrophyNCT02927080Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA95
已完成
2 期
Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple-negative Breast CancerCancer, BreastTriple Negative Breast CancerNCT03164993Oslo University Hospital68
进行中（未招募）
2 期
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial PneumoniaPneumonia, BacterialNCT05776004Eagle Pharmaceuticals, Inc.276
招募中
2 期
Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19Mild to Moderate COVID-19NCT05675072Frontier Biotechnologies Inc.1,336