to Evaluate the Efficacy and Safety of Eltrombopag for Thrombocytopenia With Chronic HBV Infection
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|ClinicalTrials.gov Identifier: NCT03664518|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia Purpura Chronic HBV Infection||Drug: Eltrombopag||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Single-arm Study to Evaluate the Efficacy and Safety of Eltrombopag for Thrombocytopenia in Chinese Patients With Chronic HBV Infection|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||May 31, 2020|
58 enrolled patients are picked up to take eltrombopag at the indicated dose.
subjects will initiate treatment with 25 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts. and maximum dose should not exceed 75 mg daily. Subjects whose platelet count between 50~150×109/L，the eltrombopag dose Maintain. platelet count between 150~250×109/L, need to reduce the dose of eltrombopag to the next lower dose or lower frequency. Subjects whose platelet count exceeds 250×109/L at any point during the treatment period, must have eltrombopag interrupted and increase the frequency of platelet monitoring to twice weekly, until platelet counts fall below 100×109/L.
- Proportion of subjects with a platelet count ≥ 50×109/L at Day 43 [ Time Frame: 6 weeks ]The proportion of subjects with a platelet count ≥ 50×109/L at Day 43 after the first 6 weeks of Eltrombopag treatment (Stage 1)
- Response rate of treatment [ Time Frame: 22 weeks ]Response rate including: a) the proportion of subjects achieving platelet counts ≥ 50×109/L at least once during the first 6 weeks (stage 1); b) the proportion of subjects whose platelet counts ≥ 30×109/L and at least two times of baseline platelet count at least once during the treatment.
- Bleeding in two stages [ Time Frame: 22 weeks ]according to the WHO bleeding grades to estimate the incidence and severity of bleeding symptoms during the treatment.
- The duration time with Platelet count ≥ 50×109/L [ Time Frame: 22 weeks ]Total duration of time a subject had a platelet count ≥ 50×109/L during treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664518
|Contact: yueting huang, MDfirstname.lastname@example.org|
|Contact: lei zhang, MDemail@example.com|
|Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Lijun Liu, Master +8613920927593 firstname.lastname@example.org|
|Principal Investigator:||lei zhang, MD||Chinese Academy of Medical Science and Blood Disease Hospital|