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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 thrombocytopenia, including thrombocytopenia due to chemotherapy, refractory immune thrombocytopenic purpura (ITP), and thrombocytopenia associated with chronic hepatitis C. It is in Phase 2 clinical development and is not approved by the FDA.
SB497115 is an oral thrombopoietin receptor agonist, meaning it targets the thrombopoietin receptor to stimulate platelet production. It is being studied in conditions characterized by low platelet counts, such as chemotherapy-induced thrombocytopenia, ITP, and hepatitis C-related thrombocytopenia.
SB497115 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials and has not yet received regulatory approval.
SB497115 is in Phase 2 clinical development. It has completed three Phase 2 trials, and no Phase 3 trials have been reported. The drug is investigational and has not been approved by the FDA or any other regulatory authority.
SB497115 has completed three Phase 2 trials: NCT00102726 in chemotherapy-induced thrombocytopenia (183 patients), NCT00102739 in refractory ITP (99 patients), and NCT00110799 in hepatitis C-related thrombocytopenia (75 patients). All trials were randomized, double-blind, and placebo-controlled.
SB497115 is the investigational code name for eltrombopag, an oral thrombopoietin receptor agonist developed by GSK. The drug has been studied under the SB497115 name in clinical trials for thrombocytopenia associated with chemotherapy, ITP, and hepatitis C.