A Phase 2 interventional study of hetrombopag 5mg po qd and High-dose Dexamethasone in ITP - Immune Thrombocytopenia, sponsored by Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Shandong University · Phase 2, Interventional, and Treatment
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks（increase daily dose to a maximum of 7.5 mg/day if platelet count\<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days
Drug: hetrombopag 5mg po qd · Drug: High-dose Dexamethasone
HD-DEX 40mg qd for 4 days
Drug: High-dose Dexamethasone
hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days
dexamethasone 40 mg qd for 4 days
26 week sustained overall response to ITP treatments
Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.
Time frame: 26-week after treatment started
28-day initial complete response to ITP treatment
Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.
Time frame: 28 days after treatment started]
28-day initial overall response to ITP treatment
Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.
Time frame: 28 days after treatment started
8-week complete response to ITP treatment
Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.
Time frame: 8 weeks after treatment started
8-week overall response to ITP treatment
No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.
Time frame: 8 weeks after treatment started
time to response
the time from treatment initiation to achieve a complete response or a partial response
Time frame: an average of 6 months
duration of response
the time from achievement of a complete response or a partial response to the loss of response
Time frame: through study completion, an average of one year
therapy associated adverse events
Time frame: through study completion, an average of one year
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Shandong University