to Evaluate the Efficacy and Safety of Eltrombopag for Thrombocytopenia With Chronic HBV Infection

Summary

Participation Requirements

Description

This is a single-arm phase II study to evaluate the efficacy and safety of Eltrombopag to treat thrombocytopenia associated with chronic hepatitis B virus infection. This study includes two stages. In Stage 1 (Week 1 to Week 6), the short-term efficacy, safety and tolerability of Eltrombopag is eval...

This is a single-arm phase II study to evaluate the efficacy and safety of Eltrombopag to treat thrombocytopenia associated with chronic hepatitis B virus infection. This study includes two stages. In Stage 1 (Week 1 to Week 6), the short-term efficacy, safety and tolerability of Eltrombopag is evaluated. At the end of Stage 1, the subjects who can benefit from Eltrombopag treatment (platelet count ? 50×109/L) can enter a 16-week prolonged stage (Stage 2) to evaluate longer-term efficacy and safety. The starting dose of Eltrombopag is 25 mg once daily, and the dose may be increased by 25 mg once daily every two weeks if the desired platelet response (>50×109/L) is not achieved. The daily dose should not exceed 75 mg. In Stage 1, weekly visits are required during the first 6 weeks of the study. In Stage 2, platelet counts will be obtained weekly during dose adjustment and every 4 weeks following establishment of a stable dose of Eltrombopag (stable dose is defined as the dose which remains unchanged for at least 2 weeks).

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