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

  • STATUS
    Recruiting
  • participants needed
    58
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 15 August 2022

Summary

Primary Objective: To evaluate the efficacy of 6-week Eltrombopag to treat thrombocytopenia associated with chronic hepatitis B virus infection. Secondary Objective: To evaluate the efficacy and safety of 6-week and 22-week Eltrombopag to treat thrombocytopenia associated with chronic hepatitis B virus infection.

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 evaluated. At the end of Stage 1, the subjects who can benefit from Eltrombopag treatment (platelet count 50109/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 (>50109/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).

Details
Condition Thrombocytopenic purpura, Chronic HBV Infection
Treatment Eltrombopag
Clinical Study IdentifierNCT03664518
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on15 August 2022

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