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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03395704 | A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis | PHASE2 | COMPLETED | 70 | — | — | Nov 29, 2017 | Oct 28, 2019 | Jun 9, 2022 | 31 | United States, Australia +2 |
Percentage change in transferrin saturation (TSAT) as measured by blood laboratory tests.
| Arm | Type | Description |
|---|---|---|
| LJPC-401 | ACTIVE_COMPARATOR | LJPC-401 solution for subcutaneous injection only, 5mg/1 mL (5mg/mL) or 10mg/1mL (10mg/mL) single use vial |
| Placebo | PLACEBO_COMPARATOR | 0.9% Sodium Chloride Injection, USP, or equivalent |
| Name | Type | Description |
|---|---|---|
| LJPC-401 | DRUG | LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg. |
| Placebo | DRUG | 0.9% Sodium Chloride Injection, USP, or equivalent |
Inclusion Criteria: 1. Patients with clinical diagnosis of hereditary hemochromatosis 2. Patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis 3. Patients with serum ferritin and TSAT levels above treatment guidelines 4. Female patients of child bearing pote...