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A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia

A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030603
Enrollment
Unknown
Registered
2020-03-08
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

The short -course glucocorticoid group:treat with glucocorticoid
The eltrombopag group:treat with eltrombopag
The rituximab group:treat with rituximab
Splenectomy group:treat with splenectomy
The azathioprine group:treat with azathioprine
The cyclosporine group:treat with cyclosporine

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient signed the informed consent, and the subject fully understood and complied with the requirements of the study protocol and was willing to complete the study as planned. 2. Aged >= 18, male or female. 3. Multiple laboratory tests showed thrombocytopenia; 4. The spleen is not enlarged or only mildly enlarged; 5. The number of megakaryocytes in bone marrow examination was increased or normal, with mature disorders; 6. Glucocorticoid-dependent patients: prednisone of > 5mg/d (or equivalent of other glucocorticoids) is required continuously, or glucocorticoids are required frequently to maintain platelet >= 30 x 10^9/L or to avoid bleeding. 7. Patients with ITP with platelet count 30 x 10^9/L and bleeding symptoms.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary thrombocytopenia; 2. Pregnant and nursing women; 3. Have a history of allergy to adrenocorticosteroids; 4. Have participated in clinical trials of other new drugs within 3 months; 5. Abnormal liver and kidney functions;Defined as serum transaminase and bilirubin >= 1.5 times the upper limit of normal. Creatinine exceeding the upper limit of normal; 6. Antibody of second liver surface antigen, hepatitis c, HIV antibody (I + II), syphilis antibody positive; 7. Patients with diabetes, hypertension, glaucoma, gastrointestinal ulcer, herpes zoster, pulmonary infection and other conditions that are not suitable for glucocorticoid maintenance therapy; 8. Patients with poor compliance; 9. Those who cannot take contraceptive measures during the experiment; 10. Any other circumstances in which the investigator considers the patient unfit to participate in this trial.

Design outcomes

Primary

MeasureTime frame
platelate counts;

Secondary

MeasureTime frame
liver function;

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