Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB-497115-GR · 2 trials · 3 indications
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.
Participants were assessed for a shift from a baseline platelet count of \<80 Gi/L to a count \>=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.
Participants were assessed for continuously maintaining platelet counts \>=50 Gi/L during Part 2. Platelet counts were measured by blood draw.
| 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. |
| SB-497115-GR | EXPERIMENTAL | investigational product for thrombocytopenia |
| 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 |
| SB-497115-GR | DRUG | TPO receptor agonist to increase platelet count |
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...
SB-497115-GR is an investigational small molecule developed by GSK plc for hematology indications. It has been studied in chronic idiopathic thrombocytopenic purpura and in chronic hepatitis C virus infection. Development has reached Phase 3, and the clinical program has been conducted in Japan.
SB-497115-GR has been studied for chronic idiopathic thrombocytopenic purpura, a condition in which platelet counts are abnormally low, and for chronic hepatitis C virus infection. Both are hematology and hepatology indications. It is an investigational agent and is not described as an approved treatment.
SB-497115-GR is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical studies of the compound, including the Phase 3 trial in chronic idiopathic thrombocytopenic purpura and the Phase 2 trial in chronic hepatitis C virus infection.
SB-497115-GR has reached Phase 3 development. The Phase 3 study in chronic idiopathic thrombocytopenic purpura is completed, and a Phase 2 study in chronic hepatitis C virus infection is also completed. No trials are currently listed as active.
Two completed trials are registered for SB-497115-GR. NCT00540423 was a Phase 3 evaluation in chronic idiopathic thrombocytopenic purpura with 23 participants. NCT01636778 was a Japanese Phase 2 study in chronic hepatitis C virus infected patients with 45 participants. Both were conducted in Japan.