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A single-arm multicenter prospective clinical study of rituximab 500 mg/m2 in glucocorticoid-ineffective or glucocorticoid-dependent primary immune thrombocytopenia

A single-arm multicenter prospective clinical study of rituximab 500 mg/m2 in glucocorticoid-ineffective or glucocorticoid-dependent primary immune thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027748
Enrollment
Unknown
Registered
2019-11-25
Start date
2020-05-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

Primary Immune Thrombocytopenia

Interventions

Test group:Rituximab (500mg/m2, once intravenously)

Sponsors

Department of Hematology, the Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old, male or female; 2. ITP patients with ineffective first-line hormone treatment or hormone dependence; 3. Platelet count <= 30 x 10^9/L or platelet count < 50 x 10^9/L with bleeding symptoms; 4. Patients who can understand the procedures and methods of this study, and are willing to sign informed consent and strictly abide by the clinical trial protocol; 5. Patients who agree to use effective contraception during the study period and within 12 months after the end of the last dose.

Exclusion criteria

Exclusion criteria: 1. Positive for HCV antibody, HBs antigen, HBc antibody and HIV antibody; 2. Secondary thrombocytopenia 3. Live vaccine was inoculated within 4 weeks before screening; 4. Active pulmonary tuberculosis; 5. Decreased renal function, serum creatinine >1.5 times normal upper limitation; 6. Abnormal liver function, upper limit of AST or ALT>2.5 times normal value; 7. Angina pectoris, heart failure, myocardial infarction, severe arrhythmia or related medical history; 8. Having or having a history of cancer; 9. A history of severe mental illness; 10. Received any monoclonal antibody therapy within the last 4 months; 11. Received any research drugs or participated in other clinical studies within 6 months before enrollment; 12. Pregnant or lactating women; 13. Other conditions deemed inappropriate by the researcher to participate in the study.

Design outcomes

Primary

MeasureTime frame
Platelets counts;

Countries

China

Contacts

Public ContactZeping Zhou

Department of Hematology, the Second Affiliated Hospital of Kunming Medical University

zhouzeping@outlook.com+86 18788571605

Outcome results

None listed

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