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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00110799 | SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C | PHASE2 | COMPLETED | 75 | — | — | Apr 1, 2005 | Nov 1, 2006 | Jun 4, 2012 | 30 | United States, France +3 |
| 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. |
| 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...