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Clinical Trials/EUCTR2005-000904-15-DE
EUCTR2005-000904-15-DEActive, not recruitingNot Applicable

Intervention with mycophenolate mofetil and daclizumab in patients with recently diagnosed type 1 diabetes mellitus - MMF/DZB Studie

George Washington University Biostatistics Center0 sites180 target enrollmentStarted: July 6, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
180
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- first diagnose of type 1 diabetes within the last 3 months
  • •- age 18-35 years
  • •- mixed meal-stimulated C-peptide > 0,2 pmol/ml
  • •- detectable islet autoantibodies
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- Body Mass Index (BMI) >95. percentile for age and sex
  • •- serological signs of HBV, HCV or HIV-infection
  • •- impaired liver function
  • •- leuco- and/or neutropenia (present or past)
  • •- chronic gastrointestinal ulcera, erosive esophagitis, inflammatory
  • •bowel disease (present or past)
  • •- positive tuberculine reaction

Investigators

Sponsor
George Washington University Biostatistics Center

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