Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
This study has been completed.
Sponsor:
Andromeda Biotech Ltd.
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Drug: DiaPep277 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
Further study details as provided by Andromeda Biotech Ltd.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 43 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644501
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644501
Locations
| 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
| Principal Investigator: | Itamar Raz, MD | Hadassah Medical Center |
More Information
| Responsible Party: | Andromeda Biotech Ltd. |
| ClinicalTrials.gov Identifier: | NCT00644501 History of Changes |
| Other Study ID Numbers: | 910 |
| Study First Received: | March 20, 2008 |
| Last Updated: | July 10, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Andromeda Biotech Ltd.:
|
type 1 diabetes beta cells immunomodulation immunointervention |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016