EUCTR2009-012221-10-FI进行中（未招募）不适用
A Phase 2a, Double Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-week Treatment With ALV003 In Patients With Well-Controlled Celiac Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18 to 75
- •History of biopsy-proven celiac disease (hospital records or the Social Insurance Institution of Finland, KELA, issued certificate)
- •Adherent to a gluten-free diet for at least 12 months prior to randomization (documented by medical history)
- •TG2 antibody negative tested using the rapid point-of-care finger tip whole blood test (Biocard TM Celiac Test, AniBiotech Ltd, Vantaa, Finland)
- •No history of acute illness for the past 4 weeks
- •Willing to undergo a 6-week gluten challenge and 2 on-study upper gastrointestinal endoscopies including multiple biopsies
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of dermatitis herpetiformis
- •History of IgE-mediated reactions to gluten
- •Any clinical contraindication to performing an endoscopy with biopsy
- •Received any systemic biologics within 6 months prior to study start
- •Chronic use of immunosuppressive medications (i.e. for autoimmune disorders or prevention of transplant rejection) 6 months prior to entry
- •Use of systemic cortisone-like medications within 28-days prior to and during study treatment
- •History of alcohol abuse or illicit drug use (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, etc.) within past 12 months
- •Laboratory values:
- •Elevated liver function tests (ALT, AST, Alk Phos and GGT > 2.5 times the upper limit of normal (ULN)
- •Bilirubin >1.5 ULN
- •Serum creatinine > 1.5 ULN
- •Hemoglobin (Hb) < 10 g/dL or 100 g/L
- •Calcium < 2.0 mmol/L
- •Platelet count <75.0 x 109 /L or 75,000/mm3
- •Partial thromboplastin time (PTT) or prothrombin time (PT/INR) > 1.5 ULN
- •Serum potassium < 3.0 mmol/L, > 5 mmol/L
- •Total white blood cell count (WBC) < 3.0 x 109 /L or 3000/mm3
- •Total lymphocyte < 1.0 x 109 /L or 1000/mm3
- •Current untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases other than celiac disease
- •Positive pregnancy test at screening and just prior to gluten challenge
- •Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)
- •Other than oral contraceptives, use of prescribed meds or over-the-counter medications that in the opinion of the Principal Investigator (PI) might interfere with study results
- •Current use of anticoagulants, including but not limited to, warfarin sodium, heparin, full-dose aspirin or clopidogrel, during the 7-day period prior to randomization
- •Received any experimental drug within 14 days of randomization; in the case of experimental biologics at least 6 months prior to randomization
- •The existence of any uncontrolled chronic disease or condition [for example HIV, hepatitis, Type 1 or 2 diabetes, or cancer (other than skin cancer)], other than celiac disease
- •Uncontrolled complications of celiac disease, which in the opinion of the PI could effect immune response, or pose an increased risk to the patient (e.g. type 1 diabetes or other autoimmune disease)
- •Known allergy or hypersensitivity to any of the components of the placebo, ALV003, E.coli, E. coli-derived proteins
- •Known adverse respiratory effects caused by sulphites
- •Any medical condition, other than celiac disease, which, in the opinion of the study PI could adversely affect the patient’s participation in the trial
研究者
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