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NCT05660785
Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia
Conditions: Non Severe Aplastic Anemia, Untreated
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 54
Sponsor: Institute of Hematology & Blood Diseases Hospital
Location: China
Summary
This is a prospective, multicenter, single-arm, phase 2 trial.
The aim of this study is to evaluate the efficacy and safety of herombopag combined with cyclosporine for patients with non severe aplastic anemia (NSAA).
Eligibility Criteria
Inclusion Criteria:Willing and able to comply with the requirements for this study and written informed consent.Male or female age ≥ 18 yearsDiagnosis of untreated non severe aplastic anemia.Platelet counts < 50 x 10^9/L at least 2 times consecutively (time interval ≥ 1 week)Exclusion Criteria:Receive immunosuppressive therapy more than 4 weeks before enrollmentTreatment with TPO-RA within 1 week before enrollmentInherited bone marrow failure syndromesBone marrow fibrosis grade ≥ 2The presence of hemolytic PNH cloneThe presence of clonal karyotypic abnormalities (del(20q), +8 and -Y are not included in this category)Previously treated with TPO-RA ≥ 4 weeksPreviously received immunosuppressive therapy ≥ 12 weeksFerritin > 1000 ng/ml (The increased level of Ferritin led by infection is not included in this category)Have an allergy to eltrombopag or any other part of this medicine.History of radiotherapy and chemotherapy for malignant solid tumorsCytopenia caused by other non-hematologic diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etcAbnormal liver function: ALT or AST > 3 ULN, or TBil > 1.5 ULN after treatment.Abnormal kidney function: Creatinine clearance < 30 ml/min, or serum creatinine (sCr) >1.5 ULNPatients with diabetic nephropathy, neuropathy, or eye diseasePatients with poorly controlled hypertension or cardiac arrhythmiaPatients with congestive heart failure and the NYHA grade ≥ 3 historically or currently, and LVEF < 45% within 4 weeks before enrollmentHistory of arteriovenous thrombosis within 1 year before enrollmentParticipation in another clinical trial within 4 months before the start of this trialPregnant or breast-feeding patientsPatients considered to be ineligible for the study by the investigator for reasons other than the above
Source: ClinicalTrials.gov (NCT05660785). StuddyBuddy aggregates publicly available trial information.