Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia (NCT05660785) | Clinical Trial Compass
CompletedPhase 2
Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia
China54 participantsStarted 2022-12-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to comply with the requirements for this study and written informed consent.
* Male or female age ≥ 18 years
* Diagnosis 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 enrollment
* Treatment with TPO-RA within 1 week before enrollment
* Inherited bone marrow failure syndromes
* Bone marrow fibrosis grade ≥ 2
* The presence of hemolytic PNH clone
* The presence of clonal karyotypic abnormalities (del(20q), +8 and -Y are not included in this category)
* Previously treated with TPO-RA ≥ 4 weeks
* Previously received immunosuppressive therapy ≥ 12 weeks
* Ferritin \> 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 tumors
* Cytopenia caused by other non-hematologic diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc
* Abnormal 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 ULN
* Patients with diabetic nephropathy, neuropathy, or eye disease
* Patients with poorly controlled hypertension or cardiac arrhythmia
* P…
What they're measuring
1
Overall response rate
Timeframe: 24 weeks
Trial details
NCT IDNCT05660785
SponsorInstitute of Hematology & Blood Diseases Hospital, China