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 sites40 target enrollmentDecember 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 23, 2016

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Center of Molecular Immunology (CIM)

•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.

•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.