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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
Record updated
5 August 2025