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A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214214
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007

September 13, 2005
December 26, 2007
October 2005
Not Provided
to determine if Campath-1H can be used in patients recently diagnosed with type I DM
Same as current
Complete list of historical versions of study NCT00214214 on ClinicalTrials.gov Archive Site
to determine if Campath-1H can eliminate or lower insulin requirements
Same as current
Not Provided
Not Provided
 
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

The rationale for the study is to determine if Campath-1H can be used in patients recently diagnosed with type I DM, to induce a state of immunological unresponsiveness such that subjects can safely preserve beta cell mass and eliminate or lower insulin requirements, preserving excellent metabolic control.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
New Onset Type 1 Diabetes Mellitus
Drug: Campath 1H® (Alemtuzumab)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
Not Provided
Not Provided

Inclusion Criteria:

  • Adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to GAD, IA2, IAA or islet cell cytoplasmic antibody (ICA) within 2 weeks of diabetes diagnosis.

Exclusion Criteria:

  • Subjects under 18 years of age or over 35 years of age.
  • Subjects who have previously received an organ transplant.
  • Subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
  • Subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., Cushing's disease, acromegaly).
  • Subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (A history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
  • Patients with a history of hepatitis B, hepatitis C, or HIV.
  • PPD positive at the time of evaluation.
  • Thrombocytopenia or neutropenia. Individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 WBC/ml.
  • Subjects with a history of renal, pulmonary, or cardiac failure
  • Subjects with severe systemic infections. Only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
Both
18 Years to 35 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214214
H-2003-0405
Not Provided
Not Provided
University of Wisconsin, Madison
Not Provided
Principal Investigator: Luis Fernandez, MD University of Wisconsin, Madison
University of Wisconsin, Madison
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP