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Interferon-Alpha for Diabetes Mellitus Type 1

NCT00024518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2013-11-19

No results posted yet for this study

Summary

This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.

Conditions

  • Insulin-Dependent Diabetes Mellitus

Interventions

DRUG

30,000 units hrINF-alpha

DRUG

5,000 hrINF-alpha

OTHER

Placebo

placebo was prepared as saline alone with 6mg human serum albumin (HSA).

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Kristina I Rother, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Staley A Brod, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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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 NCT00024518 on ClinicalTrials.gov