RPCEC00000225招募中1 期
Evaluation of the safety and therapeutic effect of the humanized anti-CD6 monoclonal antibody itolizumab (T1h) combined with insulin in the treatment of patients with type 1 diabetes mellitus
Center of Molecular Immunology (CIM)0 个研究点目标入组 40 人开始时间: 2016年12月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 35 years （—）
- 性别
- All
入选标准
- •1. Patient with a diagnosis of DM1 of not more than 12 weeks.
- •2. Patient under intensive treatment with insulin in stable dose, for at least 4 weeks before inclusion.
- •3. Patient aged 18-35 years (both included), of any sex or skin color.
- •4. Patient with stimulated C-peptide levels (MMTT) =0.2 pmol / ml, at not more than 8 weeks prior to inclusion.
- •5. Patient with clinical laboratory values: Hemogram: Hemoglobin-man = 12.0 g / dl, -women = 11.0 g / dl; Leukocytes> 4.5x109 cel / mL, Neutrophils> 1.8 x 109 / L, Lymphocytes> 1.2x109 cel / mL, Platelets> 150x109 / mL; Hepatic function: Transaminases within the normal reference values ??established in the institution (TGP <49 U / l and TGO <46 U / l); G-glutamyltransferase (GGT), men = 65 U / l, female = 45 U / l), Renal function: Creatinine <128 µmol / L
- •6. Patient who expressed in written form in their informed consent form their willingness to participate in the clinical trial.
排除标准
- •1. Patient with severe malnutrition.
- •2. Patient with a history of severe chronic diseases of the Central Nervous System, Respiratory System, Cardiovascular Apparatus, Gastrointestinal Tract, or Genitourinary System.
- •3. Patient with a history of malignant neoplasia.
- •4. Patient suffering from acquired or congenital diseases of the hemolympho- opetic system.
- •5. Patient with clinically detected acute or chronic infection (laboratory tests and chest X-rays, including HIV infection, Hepatitis B and C, Epstein Bar and Cytomegalovirus).
- •6. Patient suffering from bronchial asthma, atopic dermatitis or chronic urticaria.
- •7. Patient receiving hyperglycemic drugs (beta-blockers, ACE inhibitors, Nicotinic Acid, Interferon).
- •8. Patient with ongoing treatment or in the last six months with high doses of steroids or other immunosuppressive agents (imuran, azatriopine, methotrexate, cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate-mofetil, immunoglobulin ev [> 400 mg / kg]) .
- •9. Pregnancy, puerperium and / or breastfeeding.
- •10. Patient woman and man with reproductive capacity who refuse to avoid conception during the study.
- •11. Patient with a history of alcoholism or drug addiction.
- •12. Patient with history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody T1h.
- •13. Patient with intellectual or sensory psychological dysfunction that may impede the understanding and fulfillment of study requirements according to the Principal Investigator's criteria.
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