Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01898286 |
Date of registration:
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10/07/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
DIA-AID 2 |
Scientific title:
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Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284) |
Date of first enrolment:
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October 2013 |
Target sample size:
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38 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01898286 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Itamar Raz, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Center, Jerusalem |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients with type 1 diabetes who participated in the 1001 study
- residual beta-cell function demonstrated by stimulated C-peptide = 0.20 nmol/L.
Exclusion Criteria:
- The subject has any significant ongoing diseases or conditions that is likely to
affect the subject's response to treatment
- The subject has a history of any kind of malignant tumor.
- The subject has clinical evidence of any diabetes-related complication
- Subject has history of endogenous allergic reactivity:
- The subject has a known immune deficiency
Age minimum:
18 Years
Age maximum:
47 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes
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Intervention(s)
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Drug: DiaPep277®
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Primary Outcome(s)
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Hypoglycemic Events
[Time Frame: At Early Termination Visit, Up to 25 Months]
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Secondary Outcome(s)
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Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit
[Time Frame: Baseline and Early Termination Visit, Up to 25 Months]
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Secondary ID(s)
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2013-002775-17
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1010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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