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Withdrawn NCT05018936

Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia

Conditions: Aplastic Anemia, Drug Effect

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Sponsor: Peking Union Medical College Hospital

Location: Peking Union Medical College Hospital Beijing

Summary

This is a prospective one arm study to explore the efficacy and safety of Hetrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria would be recruited. Treatment of Hetrombopag would be started with 5mg/day. The dosage would be increased by 2.5mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L. The maximum dosage is 15mg/day. All patients would receive treatment for at least 6 months except that the platelet \

Eligibility Criteria

Inclusion Criteria: 1. Patients diagnosed to be non-severe aplastic anemia 2. Patients with platelet count \< 30×109/L and have at least one of the followings: ①absolute neutrophil count \< 1.5×109/L, ②platelet count \< 50×109/L, ③ hemoglobin level \< 100g/L 3. Patients have no response or relapsed following at least one treatment course in a period time of \> 6 months of immunosuppression containing CsA or CsA+anti-thymocyte globulin (ATG); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 5. Patients able to understand and comply with protocol requirements and instructions and have signed and dated informed consent. Exclusion Criteria: 1. Congenital aplastic anemia; 2. Presence of chromosomal aberration; 3. Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics; 4. Presence with PNH clone ≥50%; 5. Patients received HSCT before; 6. Uncontrolled infection or bleeding with standard treatment; 7. Allergic to Hetrombopag or accessories; 8. HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension; 9. Patient with QTcF (Fridericia's QT correction formula) at screening \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05018936). StuddyBuddy aggregates publicly available trial information.