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Etanercept in New Onset Type 1 Diabetes

NCT00730392 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-04-28

No results posted yet for this study

Summary

The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

Conditions

Interventions

DRUG

Etanercept

The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly

DRUG

Placebo

administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Teresa Quattrin, MD · School of Medicine and Biochemical Sciences-SUNYAB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-10-31
Completion
2008-01-31

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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 NCT00730392 on ClinicalTrials.gov