EUCTR2010-023127-23-FI进行中（未招募）不适用
A Phase 2a, Double-Blind, Placebo Controlled Trial 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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
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)
- •Adherence 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 consume a large meal (e.g. dinner) each day, adhere to a 6-week gluten challenge and undergo 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
- •Active dermatitis herpetiformis lesions at the time of screening
- •History of IgE-mediated reactions to gluten
- •Any clinical contraindication to performing an endoscopy with intestinal biopsy
- •Received any systemic biologics within 6 months prior to study start
- •Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations)
- •Use of any immunosuppressive medications 6 months prior to study start
- •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 < 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, Grade B or greater esophagitis, motility disorders such as irritable bowel syndrome, functional dyspepsia, inflammatory bowel disease, and symptomatic GERD (gastroesophageal reflux disease) 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-AIDS, 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 affect 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, or E. coli-derived proteins
- •Known adverse respiratory effects caused by sulfites
- •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
相似试验
进行中（未招募）
不适用
A study in Type 2 Diabetes Mellitus patients receiving blinded study drug to test a new study medication.MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Type 2 Diabetes MellitusEUCTR2013-004275-12-GREli Lilly and Company160
进行中（未招募）
1 期
A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary FibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersIdiopathic Pulmonary FibrosisEUCTR2019-004998-34-GBBlade Therapeutics, Inc.40
进行中（未招募）
不适用
Phase 2A clinical trial conducted on children affected by Rett syndrome and who are casually administered with the experimental treatment, EPI-743, compared versus the se of placebo.EUCTR2012-005021-76-ITEDISON PHARMACEUTICALS INC.
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 DiseaseMedDRA version: 9.1Level: LLTClassification code 10007864Term: Celiac diseaseCeliac DiseaseEUCTR2009-012221-10-FIAlvine Pharmaceuticals, Inc.107
进行中（未招募）
1 期
Clinical trial to see if there are differences in flu symptoms when people receive a single infusion of VIS410, the study medicine, compared with those who receive placebo and to find out if VIS410 is safe and well toleratedInfluenza A infectionMedDRA version: 19.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862EUCTR2015-004546-26-LVVisterra, Inc.150