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SB497115 · 3 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Arm B | ACTIVE_COMPARATOR | SB-497115-GR 30mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
| Arm C | ACTIVE_COMPARATOR | SB-497115-GR 50mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
| Arm D | ACTIVE_COMPARATOR | SB-497115-GR 75mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
| Arm A | PLACEBO_COMPARATOR | Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
| Arm 1 | ACTIVE_COMPARATOR | SB-497115-GR 50mg. administered orally daily on days 2 through 11 for each 21-day cycle. |
| Arm 2 | ACTIVE_COMPARATOR | SB-497115-GR 75 mg administered orally dailey on days 2-11 of each 21-day cycle. |
| Arm 3 | ACTIVE_COMPARATOR | SB-497115 100mg administered orally daily on days 2 through 11 of each 21-day cycle. |
| Placebo Arm | PLACEBO_COMPARATOR | Placebo administered orally daily on days 2 through 11 of each 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| SB497115 | DRUG | Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
| Placebo | OTHER | Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy. |
Inclusion criteria: * Chronic low platelet count between 20,000 and \<70,000/µL. * Prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices. Exclusion criteria: * Hi...
SB497115 is an investigational small molecule being studied for thrombocytopaenia, including in cancer patients receiving chemotherapy, adults with refractory immune thrombocytopenic purpura (ITP), and adults with thrombocytopenia due to chronic hepatitis C. It is a Phase 2 investigational drug and is not FDA approved.
SB497115 is an oral thrombopoietin receptor agonist. It targets the thrombopoietin receptor to stimulate platelet production. It is being studied in hematology for conditions involving low platelet counts, such as thrombocytopaenia and idiopathic thrombocytopenic purpura.
SB497115 is being developed by GSK plc, traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials of this investigational small molecule for thrombocytopaenia-related conditions.
SB497115 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All three known trials of SB497115 have been completed, and no active trials are currently listed.
SB497115 has three completed Phase 2 trials: NCT00102726 in cancer patients receiving chemotherapy, NCT00102739 in adults with refractory immune thrombocytopenic purpura, and NCT00110799 in adults with thrombocytopenia due to hepatitis C. All were randomized, double-blind, placebo-controlled studies.
SB497115 is the investigational code name for the drug also known as eltrombopag. It is an oral thrombopoietin receptor agonist developed by GSK plc for thrombocytopaenia. The clinical trials listed under SB497115 study this compound in various patient populations.