Status:
TERMINATED
Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
Lead Sponsor:
Andromeda Biotech Ltd.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-47 years
Phase:
PHASE3
Brief Summary
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic contr...
Detailed Description
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patie...
Eligibility Criteria
Inclusion
- patients with type 1 diabetes who participated in the 1001 study
- residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.
Exclusion
- The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
- The subject has a history of any kind of malignant tumor.
- The subject has clinical evidence of any diabetes-related complication
- Subject has history of endogenous allergic reactivity:
- The subject has a known immune deficiency
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01898286
Start Date
October 1 2013
End Date
December 1 2014
Last Update
May 26 2016
Active Locations (3)
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1
Atlanta Diabetes associates
Atlanta, Georgia, United States, 30318
2
Henry Ford Medical Centers - New Center One
Detroit, Michigan, United States, 48202
3
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803