FindTrial
Sign In

Low-Dose Cyclosporine Combined with Eltrombopag in Patients with Primary Immune Thrombocytopenia Refractory or Dependent to First-Line Glucocorticoid Treatment

Low-Dose Cyclosporine Combined with Eltrombopag in Patients with Primary Immune Thrombocytopenia Refractory or Dependent to First-Line Glucocorticoid Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125760
Enrollment
Unknown
Registered
2026-05-31
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

primary immune thrombocytopenia

Interventions

Control group:Eltrombopag
Experimental group:Low-Dose Cyclosporine Combined with Eltrombopag

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Diagnosis of primary immune thrombocytopenia (ITP) in accordance with the Chinese Guidelines for the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2025 Edition); 3. Previous ineffective response to glucocorticoid therapy or glucocorticoid dependence (requiring prednisone >=5 mg/day or frequent intermittent glucocorticoid administration to maintain platelet count >=30×10^9/L and/or avoid bleeding); 4. Platelet count =2); 5. Voluntary written informed consent obtained from the patient prior to study participation.

Exclusion criteria

Exclusion criteria: 1. Previous exposure to second-line therapies including rhTPO, TPO-RA, rituximab, etc.; 2. Past history of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism); 3. TBIL > 1.5 × ULN; 4. ALT or AST > 3 × ULN; 5. Hepatic insufficiency (Child-Pugh score > 5); 6. Serum creatinine = 1.5 mg/dL; 7. Heart disease, heart failure with New York Heart Association (NYHA) class III or higher, arrhythmias with thrombotic risk; 8. Presence of other malignancies; 9. Patients planning pregnancy or currently pregnant; 10. Any clinical history of human immunodeficiency virus, hepatitis C infection, or chronic hepatitis B infection; or presence of active infection or uncontrolled infection at screening.

Design outcomes

Primary

MeasureTime frame
The sustained remission rate at 6 months after drug withdrawal;—

Secondary

MeasureTime frame
Sustained response rate at 6 months;Overall response rate;Drug tapering and discontinuation rate;—

Countries

China

Contacts

Public ContactWu Dijiong

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

wudijiong@zcmu.edu.cn+86 139 8946 3963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026