A phase 2 clinical trial aiming to evaluate the efficacy and safety of combining hetrombopag with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP) is currently recruiting in Qilu Hospital of Shandong University in Shandong, China. Researchers expect to enroll 100 participants.
The researchers aim to investigate the potential benefits of using hetrombopag, a platelet production stimulant, in conjunction with high-dose dexamethasone. The study will be a parallel-group, randomized controlled trial with no masking.
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Participants will be divided into 2 groups. The first group will receive hetrombopag with an initial daily dose of 5 mg combined with dexamethasone, given at 40 mg per day for 4 consecutive days for 8 weeks. If their platelet count remains below 50,000 per μL after at least 2 weeks of treatment, the daily dose of hetrombopag will be increased to a maximum of 7.5 mg.
The second group will receive high-dose dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks.
The study will assess platelet count, bleeding, and other symptoms before and after treatment, as well as adverse effects associated with treatment. The trial’s primary outcome measure will be to assess the efficacy and safety of combining hetrombopag with high-dose dexamethasone as a frontline treatment for newly diagnosed ITP in adults.
Secondary outcome measures will include the 28-day initial complete response and overall response to ITP treatment, as well as the 8-week complete and overall responses. The time to respond and duration of response will also be evaluated.
To be eligible for the study, participants must be 18 years of age or older and meet the diagnostic criteria for newly diagnosed immune thrombocytopenia. Exclusion criteria include certain medical conditions and previous treatments for ITP.
The estimated study start date is July 10, 2023, and the estimated primary completion date is July 10, 2024. Follow-up will continue until December 10, 2024.
Reference
High-dose dexamethasone plus hetrombopag vs high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: a prospective, multicenter, randomized trial. ClinicalTrials.gov. Updated July 13, 2023. Accessed July 19, 2023
