Immune Thrombocytopenia (ITP)
Conditions
Interventions
Maintenance therapy with prednisone following HD-DXM (HD-DXM-P):1. Phase 1 (Days 1–4): Dexamethasone intravenous infusion, 40 mg/day × 4 days
2. Phase 2 (from Day 5 onward): Prednisone oral administration, 0.5 mg/kg/day, with weekly dose reduction of 10 mg
3. Assessment and adjustment on Day 14: If platelet count >=30×10^9/L, continue tapering prednisone
if =30×10^9/L, continue tapering prednisone
if =30×10^9/L, continue observation
if <30×10^9/L, initiate second-line therapy (e.g., rituximab, TPO-RA)
5. Note: Actual dosing regimen shall be guided by clinical practice.
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Diagnosis of ITP according to the American Society of Hematology ITP guidelines [1]; 3. Platelet count < 30 × 10^9/L both during screening and within 24 hours before first dosing; 4. Voluntarily participating in this study; fully informed and understanding of the study, with signed informed consent; willing and able to comply with and complete all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura; 2. Accompanied by severe bleeding complications, such as intracranial hemorrhage or gastrointestinal bleeding; 3. Active infection, including: (1) Known active or latent tuberculosis, including positive tuberculin skin test (PPD) or evidence of active or latent tuberculosis on chest X-ray/CT (positive skin test defined as induration >10 mm, or as per local clinical criteria); (2) Patients with known history of human immunodeficiency virus infection and/or acquired immunodeficiency syndrome; (3) Patients with active chronic hepatitis B or active hepatitis C, i.e., those positive for hepatitis B surface antigen or hepatitis C virus antibody; patients negative for hepatitis B surface antigen but positive for hepatitis B core antibody must undergo further HBV DNA testing—those with HBV DNA >=1000 IU/mL are excluded; (4) Active viral infections other than hepatitis B or C (e.g., herpes zoster); (5) Infections requiring oral or intravenous antimicrobial therapy; (6) Bacterial infections within the past 30 days, including pneumonia; 4. Pregnant or lactating females, or women of childbearing potential unwilling to use contraception; 5. Severe cardiovascular or cerebrovascular diseases within the past 3 months, such as TIA, stroke, thrombotic disease, or intracranial hemorrhage within the past 6 months; 6. Uncontrolled hypertension grade II or higher (SBP >160 mmHg and/or DBP >100 mmHg), NYHA class III/IV congestive heart failure, arrhythmias requiring drug therapy, unstable angina, or myocardial infarction; 7. Severe hepatic or renal dysfunction, including ascites, hepatic encephalopathy, esophageal or gastric varices, persistent jaundice, or cirrhosis; abnormal liver or kidney function during screening defined as serum transaminases >=2.5 times the upper limit of normal, and/or bilirubin >=1.5 times the upper limit of normal, and/or creatinine >=1.5 times the upper limit of normal; 8. Severe immunodeficiency; confirmed diagnosis of other autoimmune diseases; 9. Patients who received anticoagulants within one month prior to screening are excluded; those who received rituximab within 8 weeks, traditional Chinese medicine or patent Chinese medicine within 2 weeks, intravenous immunoglobulin, or glucocorticoids for >=3 days prior to screening are excluded; 10. Receipt of live attenuated vaccines within 4 weeks prior to first dosing, such as polio, measles, rubella, mumps, or varicella vaccines; 11. Participation in other interventional clinical trials of new drugs within 4 weeks prior to screening; 12. Patients with psychiatric disorders or inability to provide informed consent; 13. Poor compliance or other conditions deemed by the investigator as unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) at 28 days after first HD-DXM treatment;Sustained response rate (SRR) at 6 months after first HD-DXM treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained complete response rate (CRR) at 6 months after first HD-DXM treatment;Incidence of adverse reactions grade =3 after first HD-DXM treatment; | — |
Countries
China
Contacts
Public ContactWang Jing
Nanjing Drum Tower Hospital
Outcome results
None listed