The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk MDS patients with thrombocytopenia.
The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic syndromes(MDS) according to the revised International Prognostic Scoring System (IPSS-R) with thrombocytopenia. The primary endpoint was proportion of patients achieving platelet response at week 24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
All eligible patients were given hetrombopag orally at an initial dose of 5 mg once daily after overnight fasting (\>8 hours of fasting) and at least 2 hours before a meal . The dose of hetrombopag could be modified on the basis of the platelet count of patients after 2 weeks of administration.
Platelet response
proportion of patients achieving platelet responses at week 24
Time frame: 24 weeks
Overall response rate
Patients will be assessed for response according to the IWG criteria.
Time frame: 24 weeks
Proportion of patients with platelet response during treatment
Improvement in platelet counts by 24 weeks of therapy
Time frame: 24 weeks
Incidence and severity of bleeding events according to the WHO Bleeding Scale
The severity of bleeding symptoms was graded according to the World Health Organization (WHO) bleeding scale (grade 0: no bleeding; grade 1: petechiae; grade 2: mild blood loss; grade 3, gross blood loss; grade 4: debilitating blood loss).
Time frame: 28 weeks
Adverse events
Adverse events were recorded and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Time frame: 28 weeks
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