Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00644501
First received: March 20, 2008
Last updated: July 10, 2013
Last verified: July 2013

March 20, 2008
July 10, 2013
September 2008
May 2013   (final data collection date for primary outcome measure)
Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. [ Time Frame: every 6 months up to 24 months from T0 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00644501 on ClinicalTrials.gov Archive Site
improved metabolic control and the insulin dose required to maintain it. [ Time Frame: every 3 months up to 24 months from T0 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

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 expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Drug: DiaPep277
1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.
Experimental: 1
Intervention: Drug: DiaPep277
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
June 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00644501
910
Yes
Andromeda Biotech Ltd.
Andromeda Biotech Ltd.
Not Provided
Principal Investigator: Itamar Raz, MD Hadassah Medical Center
Andromeda Biotech Ltd.
July 2013

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