Skip to content

A Prospective, Single-arm, Multicenter Clinical Study of the Efficacy and Safety of Hetrombopag in the Treatment of Adults with Low-Risk Myelodysplastic Syndrome and Thrombocytopenia

A Prospective, Single-arm, Multicenter Clinical Study of the Efficacy and Safety of Hetrombopag in the Treatment of Adults with Low-Risk Myelodysplastic Syndrome and Thrombocytopenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068232
Enrollment
Unknown
Registered
2023-02-10
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndromes

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Myelodysplastic syndrome diagnosed less than 6 months, classified as very low risk, low risk or intermediate risk 6 months; 5. No platelet receptor agonists (TPO-RA, rhTPO) and IL-11 treatment within one week before treatment; 6. Liver and kidney function is sound; 7. Platelet count <= 30 x 10^9/L; 8. Willing to sign an informed consent form, can understand and comply with the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Myelodysplastic syndrome with pure 5q-; 2. Patients previously treated with demethylating agents; 3. Patients treated with TPO-RAs for >= 1 month before treatment; 4. Active uncontrolled infection and other active malignancies that may interfere with the study; 5. Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or hypotension, associated with thromboembolic risk, or events; 6. Patients with allergic reactions to drugs used in this study or similar drugs; 7. Any other condition that in the opinion of the investigator would make the subject inappropriate for the study.

Design outcomes

Primary

MeasureTime frame
Proportion of subjects with platelet response during the treatment period (24 weeks);

Secondary

MeasureTime frame
Proportion of patients with disease progression;Overall survival;The incidence and severity of bleeding during treatment;Platelet transfusion frequency during treatment;Platelet transfusion volume during treatment;Proportion of patients with disease progression;Proportion of subjects with erythroid response and neutrophil response during the treatment period (24 weeks);Time of first occurrence of platelet response;Maximum duration of platelet response and total number of days of platelet response reaching the standard;Proportion of subjects with platelet >= 50×10^9 /L during the treatment period (24 weeks) ;

Countries

China

Contacts

Public ContactHongyan Tong

The First Affiliated Hospital of Zhejiang University Medical College

hongyantong@aliyun.com+86 139 5812 2357

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026