Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501
Summary
To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-02
- Completion
- 2014-05
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo (Core Study) vs Avatrombopag 10 mg (Core Study); p = 0.0236; Difference in % of Responders 31.62 (95% CI 5.39 to 57.84); Cochran-Mantel-Haenszel NCT01355289 ↗
registry analysis (superiority or other test); Placebo (Core Study) vs Avatrombopag 20 mg (Core Study); p = 0.0003; Difference in % of Responders 60.78 (95% CI 36.30 to 85.27); Cochran-Mantel-Haenszel NCT01355289 ↗
registry analysis (superiority or other test); Placebo (Core Study) vs Avatrombopag 30 mg (Core Study); p = 0.0003; Difference in % of Responders 58.4 (95% CI 30.92 to 85.88); Cochran-Mantel-Haenszel NCT01355289 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avatrombopag | Small molecule | 10 mg | Oral |
| Subject | Avatrombopag | Small molecule | 20 mg | Oral |
| Subject | Avatrombopag | Small molecule | 30 mg | Oral |
| Background | Pegylated Interferon | Unknown | — | — |
| Background | Ribavirin | Small molecule | — | — |
| Background | Telaprevir | Small molecule | — | — |