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Study of Antithymocyte Globulin for Treatment of New-onset T1DM

NCT00515099 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-05-11

Study results available
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Summary

Antithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly used to treat and prevent organ transplant rejection. The START trial aims to determine whether antithymocyte globulin (ATG) treatment can halt the progression of newly diagnosed type 1 diabetes when given within 12 weeks of disease diagnosis.

Conditions

  • New-onset Type 1 Diabetes Mellitus

Interventions

DRUG

Antithymocyte globulin

Daily 4-day escalating dose

DRUG

Placebo

Daily 4-day saline solution

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stephen Gitelman, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-06-30
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00515099 on ClinicalTrials.gov