| Trial ID: | L2892 |
| Source ID: | NCT01661192
|
| Associated Drug: |
Aat( Alpha 1 Antitrypsin)
|
| Title: |
Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes
|
| Acronym: |
AAT Extension
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Beta Cell Preservation
|
| Interventions: |
DRUG: AAT( Alpha 1 Antitrypsin)
|
| Outcome Measures: |
Primary: Safety and tolerability of AAT in terms of adverse events and serious adverse events, We will assess at each visit until final visit (month 36)the safety and tolerability of study drug in terms of adverse events and serious adverse events, At month 36|Safety and tolerability of the AAT in terms of laboratory values, We will assess at each visit until final visit (month 36)the safety and tolerability of study drug in terms of laboratory values, At month 36 | Secondary: Beta cell function-AUC (Area Under the Curve) of stimulated C-Peptide from stimulated MMTT (mixed meal tolerance test), at month 36|Percentage of patients that maintain stimulated peak C-peptide >=0.2 nmol/L, at month 36|Percentage of patients that achieve glycemic target of HbA1c <=7.5%, At month 36|Daily insulin dose adjusted to body weight, At month 36
|
| Sponsor/Collaborators: |
Sponsor: Rabin Medical Center | Collaborators: Kamada, Ltd.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2013-01
|
| Completion Date: |
2017-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-11
|
| Locations: |
Schneider Children's Medical Center, Petah-Tikva, 49202, Israel|Assaf Haroffeh Medical Center, Zerifin, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT01661192
|
