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Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00644501
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: DiaPep277 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)
Study Start Date : September 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. improved metabolic control and the insulin dose required to maintain it. [ Time Frame: every 3 months up to 24 months from T0 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644501


Locations
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Israel
Wolfson Medical Centre
Holon, Israel, 58100
Diabetic Unit, Hadassah Medical Center
Jerusalem, Israel, 91120
Schneider Children's Medical Centre
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Andromeda Biotech Ltd.
Investigators
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Principal Investigator: Itamar Raz, MD Hadassah Medical Center
More Information
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Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00644501    
Other Study ID Numbers: 910
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Andromeda Biotech Ltd.:
type 1 diabetes
beta cells
immunomodulation
immunointervention
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases