| Trial ID: | L7329 |
| Source ID: | NCT01460251
|
| Associated Drug: |
Diapep277
|
| Title: |
OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: DiaPep277
|
| Outcome Measures: |
Primary: Adverse events, month 38|DiaPep277-specific antibodies, month 38 | Secondary: Beta cell function-AUC of stimulated C-peptide from stimulated MMTT measured by radioimmunoassay, month 38|Percentage of patients that maintain stimulated C-peptide >/= 0.2nmol/L, month 38|percentage of patients that achieve glycemic target of HbA1c</=7%, month 38|Daily insulin dose adjusted to body weight at study end, month 38
|
| Sponsor/Collaborators: |
Sponsor: Rabin Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2015-02
|
| Results First Posted: |
|
| Last Update Posted: |
2015-03-19
|
| Locations: |
Hadassah Medical Center, Jerusalem, 91120, Israel|Schneider Children's Medical Center, Petah-Tikva, 49202, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT01460251
|
