Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Medical University
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of type 1 diabetes

• The age of subjects between 8 and 45 years old

• Course of disease within 1 year

• Presence of at least one type of detectable islet autoantibody [zinc transporter 8 antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)]

• Stimulated peak C-peptide levels of at least 0.2 pmol/mL

Exclusion Criteria:

• Confirmed diagnosis of type 2 diabetes

• Severe chronic or acute complications of diabetes

• Severe infection or damage to the immune response

• Presence of chronic latent infection in vivo

• Viral hepatitis B patients whose hepatitis B virus(HBV)DNA > log10^5

• Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate aminotransferase(AST), and creatinine more than 2 times the upper limit of normal

• Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤ 60mmHg

• Patients with rheumatoid arthritis

• Allergic to any component of this drug

• Pregnancy, breast-feeding women

• Use of other immunosuppressive agents 3 months before selected