EUCTR2009-011606-41-BE进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus - Protégé Encore
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Subjects must have met all of the following criteria:
- •- Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria.
- •- Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
- •- Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
- •- Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening :
- •a. Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- •b. Glutamic acid decarboxylase (GAD) autoantibodies, or
- •c. Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive)
- •- Subjects 8–35 years old; France only: Subjects 18–35 years old
- •- Body weight = 36 Kg
- •- BSA =2.4 m2 (Interactive Voice Response System [IVRS] will be used to calculate BSA using the Mosteller formula )
- •Are the trial subjects under 18? yes
- •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 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must not have had any of the following criteria:
- •- Prior administration of a monoclonal antibody—within the 1 year before randomization at Study Day 0
- •- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
- •- Prior murine OKT®3 treatment or other anti-CD3 treatment
- •- Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
- •- Current treatment with oral antidiabetic agents
- •- Evidence of active infection
- •- History of or positive test for human immunodeficiency virus (HIV)
- •- History of or positive tests for hepatitis B, C or D
- •- Evidence of active or latent tuberculosis (TB), which may include a positive purified protein derivative (PPD) skin test result (= 10 mm induration); a chest X-ray consistent with TB or household contact with a person with active TB, unless appropriate isoniazid (INH) prophylaxis for tuberculosis (TB) was previously given
- •- Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 (Study Day 364) of the study:
- •a. Influenza vaccinations with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing course.
- •b. Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing course
- •- Any infectious mononucleosis-like illness within the 6 months before randomization
- •- Serologic or clinical evidence of acute infection with Epstein-Barr virus (EBV), including a positive Epstein-Barr virus (EBV) immunoglobulin M (IgM). (Viral load does not have to be positive)
- •- Serologic evidence of acute infection with cytomegalovirus (CMV), defined as a positive cytomegalovirus (CMV) immunoglobulin G (IgG) and a positive viral load
研究者
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