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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00540423 | Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | PHASE3 | COMPLETED | 23 | — | — | Sep 1, 2007 | Dec 1, 2008 | Mar 30, 2011 | 7 | Japan |
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
| Arm | Type | Description |
|---|---|---|
| SB-497115-GR group | EXPERIMENTAL | Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. |
| placebo group | PLACEBO_COMPARATOR | Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo. |
| Name | Type | Description |
|---|---|---|
| SB-497115-GR 12.5mg | DRUG | SB-497115-GR 12.5mg tablet once a day |
| SB-497115-GR 25mg | DRUG | SB-497115-GR 25mg tablet once a day |
| SB-497115-GR 12.5mg matching placebo | DRUG | SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day |
| SB-497115-GR 50 mg | DRUG | SB-497115-GR 25mg tablet x2 once a day |
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria. At Screening (Week -4 or -3) * Diagnosed with ITP for at least 6 months prior to screening. * Have a platelet count of \<30,000/µL. * Previously treated refractory or relapsed patients who h...