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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03378531 | A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency | PHASE2 | COMPLETED | 14 | — | — | Dec 7, 2017 | Dec 15, 2022 | Jul 27, 2023 | 7 | United States, Canada +2 |
| NCT02488044 | A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency | PHASE1 | COMPLETED | 16 | — | — | Jun 1, 2016 | Feb 1, 2019 | Jun 12, 2019 | 9 | United States, Canada +2 |
Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs
| Arm | Type | Description |
|---|---|---|
| AEB1102 | EXPERIMENTAL | Each patient may receive AEB1102 administered IV for up to approximately 4 years. |
| Name | Type | Description |
|---|---|---|
| AEB1102 | DRUG | modified human arginase I |
Inclusion Criteria: 1. Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing 2. Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient...