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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02125877 | Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet) | PHASE2 | COMPLETED | 173 | — | — | Jul 8, 2014 | Feb 24, 2016 | Jul 25, 2017 | 51 | United States, Argentina +14 |
The percentage of participants with adverse events, serious adverse events and deaths was assessed.
The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.
| Arm | Type | Description |
|---|---|---|
| Deferasirox dispersible tablet (DFX-DT) | ACTIVE_COMPARATOR | Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose. |
| Deferasirox film-coated tablet (DFX-FCT) | EXPERIMENTAL | Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose |
| Name | Type | Description |
|---|---|---|
| Deferasirox dispersible tablet | DRUG | Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use. |
| Defearisox film-coated tablet | DRUG | Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use. |
Key Inclusion Criteria: * Male and female patients aged ≥ 10 years * Patients with transfusion-dependent thalassemia and iron overload, requiring deferasirox DT at doses of ≥ 30 mg/kg/day as per the investigator's decision OR Patients with very low, low or intermediate (int) risk myelodysplastic sy...