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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01186419 | Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload | PHASE2 | COMPLETED | 51 | — | — | Aug 13, 2010 | Jan 8, 2013 | Jun 10, 2021 | 9 | United States, Italy +3 |
LIC was determined by R2 Magnetic Resonance Imaging (MRI).
| Arm | Type | Description |
|---|---|---|
| SPD602 (16mg) | EXPERIMENTAL | - |
| SPD602 (32mg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SPD602 (FBS0701, SSP-004184) | DRUG | Oral FBS0701 taken one time daily for up to 96 weeks. |
Inclusion Criteria: * Transfusional iron overload due to: hereditary anemias such as sickle cell disease, β-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. Patients must also be transfusion-dependent and require chro...