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

NCT01280682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-12-11

Study results available
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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.

Conditions

Interventions

DRUG

rituximab

anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Sponsors & Collaborators

  • Yang Tao

    lead OTHER

Principal Investigators

  • Tao Yang, MD/PhD · First Affiliated Hospital, Nanjing Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280682 on ClinicalTrials.gov