Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
Megadott ok: The ethical application for the institution was not completed, and the research was not carried out.
A legfontosabb adatok
- Fázis
- 2/3. fázis
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A vizsgálat adatai
- Ki végzi
- Peking Union Medical College Hospital
- Azonosító
- NCT05018936
- A regiszteradat frissítve
- 2026. június 8.
- Eredeti leírás
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 <20×10e9/L at the dosage of 15mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 5mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at D15, 1month, 1.5month, 2month, 3month, 4month, 5month, 6month, 8month, 10month and 1year.A teljes eredeti leírásKevesebb
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia: a Prospective Single Arm Study
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 <20×10e9/L at the dosage of 15mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 5mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at D15, 1month, 1.5month, 2month, 3month, 4month, 5month, 6month, 8month, 10month and 1year.
Bevonási feltételek: Patients diagnosed to be non-severe aplastic anemia; 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; 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); Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Patients able to understand and comply with protocol requirements and instructions and have signed and dated informed consent.
Kizáró feltételek: Patients received HSCT before; Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin; Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics; Uncontrolled infection or bleeding with standard treatment; Allergic to Hetrombopag or accessories; HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension; Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants; Patient with QTcF (Fridericia's QT correction formula) at screening <450 msec, or<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site, unstable angina pectoris, uncontrolled hypertension(>180/100mmHg)，pulmonary artery hypertension; Congenital aplastic anemia; Presence of chromosomal aberration; Presence with PNH clone ≥50%; Pregnant or nursing (lactating) woman; Have attended other clinical trials within 3 months.