Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia

• Status: Recruiting
• Trial end date: 2025-05-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborator: Jiangsu Hengrui Pharmaceuticals Co.,Ltd
• Treatments: Cyclosporine; Cyclosporins

Criteria

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

• Patients with congestive heart failure and the NYHA grade ≥ 3 historically or currently, and LVEF < 45% within 4 weeks before enrollment

• History of arteriovenous thrombosis within 1 year before enrollment

• Participation in another clinical trial within 4 months before the start of this trial

• Pregnant or breast-feeding patients

• Patients considered to be ineligible for the study by the investigator for reasons other than the above