Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Andromeda Biotech Ltd.

ClinicalTrials.gov Identifier:

NCT00644501

First received: March 20, 2008

Last updated: September 14, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2008
Last Updated Date	September 14, 2011
Start Date ^ICMJE	September 2008
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00644501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 23, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Official Title ^ICMJE	Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 1 Diabetes
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 1 Intervention: Drug: DiaPep277
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	December 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 48 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00644501
Other Study ID Numbers ^ICMJE	910
Has Data Monitoring Committee	Yes
Responsible Party	Andromeda Biotech Ltd.
Study Sponsor ^ICMJE	Andromeda Biotech Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Andromeda Biotech Ltd.
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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