CompletedPhase 2
Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia
Key facts
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Where
- China4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 54 people enrolled
- Started
- 1 Dec 2022
- Ended
- 28 Jan 2025
- Type of study
- Interventional
- Treatments tested
- Herombopag
- Record updated
- 5 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Receive immunosuppressive therapy more than 4 weeks before enrollment
- Treatment with TPO-RA within 1 week before enrollment
- Previously treated with TPO-RA ≥ 4 weeks
- Previously received immunosuppressive therapy ≥ 12 weeks
- Participation in another clinical trial within 4 months before the start of this trial
- Inherited bone marrow failure syndromes
- 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
- Patients with diabetic nephropathy, neuropathy, or eye disease
- Patients with poorly controlled hypertension or cardiac arrhythmia
- History of arteriovenous thrombosis within 1 year before enrollment
- 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 congestive heart failure and the NYHA grade ≥ 3 historically or currently, and LVEF < 45% within 4 weeks before enrollment
- 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)
- Pregnant or breast-feeding patients
- Patients considered to be ineligible for the study by the investigator for reasons other than the above
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The group in the trial
- CsA + HerombopagTreatment being tested
Herombopag combined with cyclosporine
Treatment: Herombopag
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Efficacy and Safety of Herombopag Combined With Cyclosporine for Patients With Non Severe Aplastic Anemia
- Publications
- Hetrombopag Added to Cyclosporine as the First-Line Treatment for Patients With Non-Severe Aplastic Anemia: A Phase 2 Multicenter Trial.American journal of hematology, 2026
- Record updated
- 5 August 2025