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Clinical study for the safety and efficacy of short-course glucocorticoid therapy in newly diagnosed patients with primary immune thrombocytopenia who are effective with initial hormone therapy

Clinical study for the safety and efficacy of short-course glucocorticoid therapy in newly diagnosed patients with primary immune thrombocytopenia who are effective with initial hormone therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027747
Enrollment
Unknown
Registered
2019-11-25
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Primary Immune Thrombocytopenia

Interventions

Short-course glucocorticoid group:Glucocorticoid decreased within 1 week
Routine glucocorticoids group:Glucocorticoid doses gradually decrease
Short-course low dose glucocorticoid maintenance group:Small doses of glucocorticoids maintained

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients who sign the informed consent, and fully understand and complie with the requirements of the study protocol; 2) Aged >=18 years old, male or female; 3) Multiple laboratory tests showed thrombocytopenia; 4) No or only mild enlargement of spleen; 5) The number of megakaryocytes in bone marrow examination is increased or normal, and there is maturation disorder; 6) Except all kinds of secondary thrombocytopenia; 7) Newly diagnosed ITP patients (within 3 months after diagnosis); 8) ITP patients with complete response (platelet >=100x10^9/L) after initial hormone therapy.

Exclusion criteria

Exclusion criteria: 1) Patients with secondary thrombocytopenia; 2) If the initial treatment is intravenous immunoglobulin, patients with ineffective hormone therapy should be excluded; 3) Pregnant and lactating women; 4) Patients with a history of allergy to adrenocorticosteroids; 5) Patients who have participated in clinical trials of other new drugs within 3 months; 6) Abnormal liver and kidney function: defined as serum transaminase and bilirubin >=1.5 times the upper limit of normal value, creatinine exceeds the upper normal limit; 7) Antibody of second liver surface antigen, hepatitis c, HIV antibody (I+II), syphilis antibody positive; 8) Patients complicated with diabetes, hypertension, glaucoma, digestive tract ulcer, herpes zoster, lung infection and other diseases that are not suitable for glucocorticoid maintenance treatment; 9) Patients with poor compliance; 10) Unable to take contraceptive measures during the test; 11) The investigator considers that the patient should not participate in this study under any other circumstances.

Design outcomes

Primary

MeasureTime frame
platelets;

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