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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02005848 | Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes | PHASE2 | COMPLETED | 70 | — | — | Apr 1, 2014 | Feb 1, 2017 | Oct 11, 2018 | 4 | Israel |
Beta cell function (measured by C peptide)
| Arm | Type | Description |
|---|---|---|
| Alpha1 Antitrypsin (Glassia) | EXPERIMENTAL | 60 mg/kg body weight |
| Alpha-1 Antitrypsin (Glassia) | EXPERIMENTAL | 120 mg/kg body weight |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Alpha-1 Antitrypsin | BIOLOGICAL | - |
| Placebo | OTHER | Placebo |
Main Inclusion Criteria: * Subject (or parent/guardian) willing and able to sign an informed consent * Age 8-25 (inclusive) years * Recently diagnosed with T1DM * Basal C-peptide ≥ 0.2 pmol/mL * Positive for at least one diabetes-related autoantibody * Ability and consent to comply with completion ...