Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andromeda Biotech Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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