Prevention of Diabetes Progression Trial (PDPT)

NCT00198146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-08-11

No results posted yet for this study

Summary

The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.

Conditions

  • Newly Diagnosed With Type 1 Diabetes

Interventions

DRUG

Zenapax

Sponsors & Collaborators

  • Pescovitz, Mark D., M.D.

    collaborator INDIV
  • Roche Pharma AG

    collaborator INDUSTRY
  • Facet Biotech

    collaborator INDUSTRY
  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Mark D Pescovitz, M.D. · Indiana University - Riley Hospital for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2007-02-23
Completion
2007-02-23

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 NCT00198146 on ClinicalTrials.gov