Primary Immune Thrombocytopenia
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years; 2. Meet the following ITP diagnostic criteria (according to the 2020 edition of the Chinese Expert Consensus on the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults): (1) At least 2 consecutive blood routine examinations showed a decrease in platelet count, and there was no obvious abnormality in the morphology of blood cells in peripheral blood smear microscopy; (2) The spleen is not enlarged or only slightly enlarged; (3) The number of megakaryocytes in bone marrow examination is increased or normal, and there is a maturity disorder; (4) Excluding various secondary thrombocytopenia; 3. Patients who have been treated with glucocorticoids but have poor treatment effect or have contraindications to the use of adrenal corticosteroids; 4. ITP patients with ineffective splenectomy; 5. ITP patients who are ineffective with other second-line drugs; 6. Patients who can understand and treat according to the research protocol, and who sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in any clinical trial within 28 days before the initial screening/or the 5-fold half-life of the research compound (whichever is longer); 2. Abnormal liver and kidney function; defined as serum transaminase and bilirubin >= 1.5 times the upper limit of normal. Creatinine above the upper limit of normal; 3. Hepatitis B surface antigen, hepatitis C antibody, HIV antibody (?+?), syphilis antibody positive; 4. Patients with immunodeficiency, uncontrolled severe infection and active or recurrent peptic ulcer; 5. Allergic reaction: history of allergy to human-derived biological products; 6. Those who received live vaccines in the last month; 7. Use B-cell targeted therapy drugs, such as Rituxan or Epalizumab, etc. within one year; 8. Pregnant patients, breastfeeding patients and patients who have childbearing plans in the past 12 months; 9. Use tumor necrosis factor inhibitors and interleukin receptor blockers within one year; 10. Those who use intravenous gamma globulin (IVIG), prednisone >= 100 mg/d for more than 14 days or undergo plasmapheresis within one month; 11. Mental patients with depression or suicidal thoughts; 12. Any other circumstances in which the investigator believes that the patient should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelets counts; | — |
Countries
China
Contacts
Public ContactZhou Zeping
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed