EUCTR2009-011606-41-ES进行中（未招募）不适用
Estudio de fase 3, aleatorizado, en doble ciego, controlado con placebo y multinacional, para evaluar la eficacia y la seguridad de teplizumab (MGA031), un anticuerpo monoclonal anti-CD3 que no se une al FcR, humanizado, en niños y adultos con diabetes mellitus de tipo 1 de presentación reciente // 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
- 不适用
- 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 meet all of the following criteria:
- •1. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria (Appendix A)
- •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
- •3. Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
- •4. Currently receiving insulin therapy
- •5. Detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay)
- •6. Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies:
- •a. Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- •b. Glutamic acid decarboxylase (GAD) autoantibodies, or
- •c. Insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
- •7. Subjects 8?35 years old
- •8. Body weight >or = 36 Kg
- •9. BSA < or = 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 728). 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 (See Appendix E)
- •10. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
- •11. Untreated hypothyroidism or active Graves' disease
- •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 corticosteroids during the trial are also excluded
- •14. Evidence of active infection
- •15. Known or suspected infection with human immunodeficiency virus (HIV)
- •16. History of or positive tests for hepatitis A, B, C, D, or E
- •17. Total bilirubin > 1.5 x upper limit of normal (ULN)
- •18. AST or ALT > 1.5 x ULN
- •19. Evidence of active or latent tuberculosis (TB), which may include a positive purified protein derivative (PPD) skin test result (> or = 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
- •20. Vaccination with a live virus within the 8 weeks before randomization or planned live virus vaccination continuing through Week 52 of the study. Vaccination with an antigen or killed organism must not be given within 8 weeks before or planned within 8 weeks after each dosing cycle
- •21. Any infectious mononucleosis-like illness within the 6 months before randomization
- •22. 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)
- •23. Serologic evidence of acute infection with cytomegalovirus (CMV), defined as a positive cytomegalovirus (CMV) immunoglobulin G (IgG) and a positive viral load
- •24. Decreased lymphocytes (< 1000 lymphocytes/µL)
- •25. Decreased neutrophils (< 1000 PMN/µL on 2 consecutive evaluations performed on different days)
- •26. Decreased platelet count (< 150,000 platelets/µL)
- •27. Decreased hemoglobin (Hgb < 10 grams/deciliter [g/dL])
- •28. Investigative site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child or s
研究者
相似试验
进行中（未招募）
1 期
Estudio de fase III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos sobre la seguridad y la eficacia de BI 10773 (10 mg y 25 mg administrados por vía oral una vez al día) durante 52 semanas en pacientes con diabetes mellitus de tipo 2 y control glucémico insuficiente en tratamiento con una pauta de múltiples inyecciones diarias (MID) de insulina en monoterapia o con metforminaA phase III, randomized, double-blind, placebo-controlled, parallelgroup safety and efficacy study of BI 10773 (10 mg and 25 mgadministered orally once daily) during 52 weeks in patients with type 2diabetes mellitus and insufficient glycemic control on MDI insulinregimen alone or with metformin.Diabetes mellitus tipo 2.Type 2 diabetes mellitusMedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2010-019968-37-ESBoehringer Ingelheim España, S.A.555
进行中（未招募）
1 期
Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad durante 48 semanas del bromuro de tiotropio inhalado oralmente (2,5 μg y 5 μg una vez al día) administrado con el inhaladorRespimat® a adolescentes (12 a 17 años) con asma moderado persistente.A Phase III randomised, double blind, placebo-controlled, parallel group study to assess the efficacy and safety over 48 weeks of orally inhaled Tiotropium bromide (2.5 µg and 5 µg once daily ) delivered by the Respimat® inhaler in adolescents (12 to 17 years old) with moderate persistent asthmaAsma moderado persistente.Moderate persistent asthma.MedDRA version: 12.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2010-021093-11-ESBoehringer Ingelheim España, S.A673
进行中（未招募）
1 期
Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y con grupos paralelos, sobre la eficacia y seguridad de BI 10773 (10 mg y 25 mg administrado una vez al día) añadido a un tratamiento antidiabético preexistente durante 52 semanas en pacientes con diabetes tipo 2 e insuficiencia renal con un control glucémico insuficiente.A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control.EUCTR2009-016179-31-ESBoehringer Ingelheim España, S.A.682
进行中（未招募）
不适用
Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDSEUCTR2008-008337-11-ESPfizer, S.A.750
进行中（未招募）
不适用
Estudio de fase III, aleatorizado, doble ciego y controlado frente a placebo para evaluar la eficacia y la seguridad de 10 mg de ZD4054 en combinación con docetaxel frente a docetaxel en pacientes con cáncer de próstata hormonorresistente con metástasis.A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer - ENTHUSE-M1CEUCTR2007-003228-39-ESAstraZeneca AB1,044