Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01661192 | Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes | PHASE2 | COMPLETED | 12 | — | — | Jan 1, 2013 | Jan 1, 2017 | Jan 11, 2017 | 2 | Israel |
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
We will assess at each visit until final visit (month 36)the safety and tolerability of study drug in terms of laboratory values
| Arm | Type | Description |
|---|---|---|
| AAT( Alpha 1 Antitrypsin) | EXPERIMENTAL | Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L will continue treatment with AAT according to the dosage group they were allocated to at the previous study(40mg/kg or 60mg/kg or 80mg/kg), intravenously, once a week for 6 consecutive weeks, at 24-week intervals for a duration of \~54 weeks. |
| Follow up group | NO_INTERVENTION | Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L or subjects with peak stimulated C -peptide secretion ≥ 0.2nmol/L who are reluctant to receive additional study drug, will be followed up only with no administration of investigational product |
| Name | Type | Description |
|---|---|---|
| AAT( Alpha 1 Antitrypsin) | DRUG | - |
Inclusion Criteria: * Subject (or parent/guardian) willing and able to sign an informed consent * Ability to comply with all study requirements. * A patient that participated in Study 008 and received all doses of study medication, per protocol. * Evidence of clinically significant residual beta-ce...