EUCTR2009-011606-41-PL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:
- •1. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria.
- •2. Written informed consent obtained from the subject (assent will be obtained for subjects under age 18 years,
- •according to all applicable regulations) including consent for the use of research-related health information at screening
- •3. Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
- •4. Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug.
- •5. Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
- •6. 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)
- •7. Subjects 8–35 years old
- •8. Body weight = 36 Kg
- •9. BSA =2.4 m2 (Interactive Voice Response System [IVRS] will be used to calculate BSA using the Mosteller formula )
- •10. Sexually active females, unless surgically sterile, must be willing to use 2 forms of contraception through the end of the study (Study Day 546 for subjects who received 1 course of study medication and study day728 for subjects who received 2 courses of study medication). Acceptable forms of contraception for female subjects
- •include: oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner, or sterile sexual partner.
- •Abstinence is an acceptable form of contraception only if it is the subject’s pre-existing method of contraception.
- •Male subjects with partners of child-bearing potential should use barrier contraception in addition to having their
- •partners use another method of contraception
- •11. Willing to forego other forms of experimental treatment during the study
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must have none of the following:
- •1. Prior administration of a monoclonal antibody—within the 1 year before randomization at Study Day 0
- •2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before
- •randomization at Study Day 0
- •3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- •4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
- •5. Prior murine OKT®3 treatment or other anti-CD3 treatment
- •6. 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
- •7. Current treatment with oral antidiabetic agents
- •8. Current or planned therapy with inhaled insulin, if it becomes available
- •9. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease or
- •other serious cardiac disease as described in New York Heart Association (NYHA) Class III or IV criteria within
- •the 12 weeks before randomization
- •10. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or
- •cerebrovascular disease
- •11. Untreated hypothyroidism or active Graves’ disease at Study Day 0
- •12. Eczema, asthma or severe atopic disease requiring treatment, including topical or inhaled corticosteroids,
- •within the 12 weeks before randomization
- •13. Treatment with systemic glucocorticoid therapy by oral, intravenous (IV), intramuscular (IM), or inhaled route within 12 weeks before randomization; patients who are likely to require treatment with systemic corticosteroids during the trial are also excluded
- •14. Evidence of active infection
- •15. History of or positive test for human immunodeficiency virus (HIV)
- •16. Positive immunoglobin M (IgM) test for hepatitis A
- •17. History of or positive test for hepatitis B, C or D
- •18. Total bilirubin > 1.5 x upper limit of normal (ULN)
- •19. AST or ALT > 1.5 x ULN
- •20. Evidence of active or latent tuberculosis (TB), which may include a positive purified protein derivative (PPD)
- •skin test result; 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
- •21. Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 (Study Day 364) of the study.
- •- Influenza vaccinations with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing course.
- •- Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing course
- •22. Any infectious mononucleosis-like illness within the 6 months before randomization
- •23. 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)
- •24. Serologic evidence of acute infection with cytomegalovirus (CMV), defined as a positive cytomegalovirus (CMV) immunoglobulin G (IgG) and a positive viral load
- •25. Decreased lymphocytes (< 1000 lymphocytes/µL)
- •26. Decreased neutrophils (< 1000 polymorphonuclear neutrophil (PMN)/µL on 2 consecutive evaluations performed on different days)
- •27. Decreased platelet count (< 150,000 platelets/µL)28. Decreased hemoglobin (Hgb < 10 grams/deciliter [g/dL])
- •29. Investigative site
研究者
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