Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)
Summary
The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload
Timeline
- Start
- 2012-08-14
- Primary completion
- 2014-04-24
- Completion
- 2014-04-24
Outcome
Missed primary endpoint
Stopped: “This study was terminated due to treatment stop resulting in an inability to draw conclusions from the data. Evaluation of nonclinical rat findings is ongoing.”
registry analysis (unspecified test); SSP-004184AQ; p = 0.0560; paired t-test; note: P-value was from paired t-test for post treatment timepoint versus baseline. NCT01671111 ↗
registry analysis (unspecified test); SSP-004184AQ; p = 0.1232; paired t-test; note: P-value was from paired t-test for post treatment timepoint versus baseline. NCT01671111 ↗
registry analysis (unspecified test); SSP-004184AQ; p = 0.1319; paired t-test; note: P-value was from paired t-test for post treatment timepoint versus baseline. NCT01671111 ↗
registry analysis (unspecified test); SSP-004184AQ; p = 0.8061; paired t-test; note: P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline. NCT01671111 ↗
registry analysis (unspecified test); SSP-004184AQ; p = 0.2297; paired t-test; note: P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline. NCT01671111 ↗
registry analysis (unspecified test); SSP-004184AQ; p = 0.1248; paired t-test; note: P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline. NCT01671111 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SPD602 | Unknown | 8 mg/kg | Oral |
| Subject | SPD602 | Unknown | 75 mg/kg | Oral |