Status:
COMPLETED
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Lead Sponsor:
Andromeda Biotech Ltd.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-48 years
Phase:
PHASE3
Brief Summary
The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The...
Eligibility Criteria
Inclusion
- A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
- Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.
Exclusion
- The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
- The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00644501
Start Date
September 1 2008
End Date
June 1 2013
Last Update
July 11 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Wolfson Medical Centre
Holon, Israel, 58100
2
Diabetic Unit, Hadassah Medical Center
Jerusalem, Israel, 91120
3
Schneider Children's Medical Centre
Petah Tikva, Israel, 49202