A Phase 3 interventional study of DiaPep277 in Type 1 Diabetes, sponsored by Rabin Medical Center. Terminated at 2 sites in Israel. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-03-19.
Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment
The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study
The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 2 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study. The optimal dose and dosing regimen for this study will be the same as applied in the phase 3 study (901) and its extension study protocol (910), namely 1.0 mg DiaPep277® administered every 3 months. These conditions were determined as optimal based on the outcome of the phase 2 studies. For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
Drug: DiaPep277
1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
Adverse events
Time frame: month 38
DiaPep277-specific antibodies
Time frame: month 38
Beta cell function-AUC of stimulated C-peptide from stimulated MMTT measured by radioimmunoassay
Time frame: month 38
Percentage of patients that maintain stimulated C-peptide >/= 0.2nmol/L
Time frame: month 38
percentage of patients that achieve glycemic target of HbA1c</=7%
Time frame: month 38
Daily insulin dose adjusted to body weight at study end
Time frame: month 38
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DiaPep 277