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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 being studied for chronic idiopathic thrombocytopenic purpura (ITP) and chronic hepatitis C. In clinical trials, it has been evaluated in Japanese patients with these conditions. The drug is not approved and remains in clinical development.
SB-497115-GR is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted clinical trials of the drug in Japan for chronic idiopathic thrombocytopenic purpura and chronic hepatitis C.
SB-497115-GR has been studied in Phase 3 and Phase 2 clinical trials. A Phase 3 trial in chronic idiopathic thrombocytopenic purpura has been completed, and a Phase 2 trial in chronic hepatitis C has also been completed. The drug is investigational and not approved.
SB-497115-GR has been evaluated in two completed clinical trials. NCT00540423 was a Phase 3 study in chronic idiopathic thrombocytopenic purpura with 23 participants. NCT01636778 was a Phase 2 study in chronic hepatitis C with 45 participants. Both trials were conducted in Japan.
SB-497115-GR is an alternative name for eltrombopag, a small molecule thrombopoietin receptor agonist. In clinical trials, it has been studied for chronic idiopathic thrombocytopenic purpura and chronic hepatitis C. The drug is developed by GSK plc.