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Evaluation of clinical efficacy of low-dose corticosteroid combined with low-dose eltrombopag in newly diagnosed immune thrombocytopenia: a non-randomized controlled study

Evaluation of clinical efficacy of low-dose corticosteroid combined with low-dose eltrombopag in newly diagnosed immune thrombocytopenia: a non-randomized controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058259
Enrollment
Unknown
Registered
2022-04-04
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Immune Thrombocytopenia (ITP)

Interventions

Experimental group:Low-dose corticosteroid combined with low-dose eltrombopag
Control group:Regular-dose dexamethasone or prednisone

Sponsors

Zhejiang Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. In line with the newly diagnosed ITP diagnosis, bone marrow aspiration results were not used as the key evaluation criteria, and patients with decreased megakaryocyte number could be included, but other secondary causes of thrombocytopenia should be excluded; 2. Without hormone therapy, patients who did not respond to rhTPO or IVIG therapy could be included, but a 30-day washout period was required; 3. Platelet count =2); 4. Did not participate in other clinical studies; 5. Aged >12 and <=60 years; 6. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Any clinically relevant abnormalities (other than ITP) or any other medical condition or condition found during screening that the investigator deems the subject unfit for study participation; 2. With a history of platelet aggregation, platelet count cannot be measured reliably; 3. Patients with any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) and >= 2 of the following risk factors: hormone replacement therapy, smoking, diabetes, hypercholesterolemia, hypertension medications, cancer, genetic thromboembolism (e.g., coagulation factor V Leiden, antiphospholipid syndrome, etc.); 4. Heart disease (Class II/III/IV of the modified ROSS scale for Pediatric Heart Failure) should not be included; Arrhythmias at risk of thrombosis (such as atrial fibrillation), pulmonary hypertension, or uncontrolled hypertension (>180/100 mmHg); 5. Any clinical history of hepatitis C infection or chronic hepatitis B infection; Or any evidence of active hepatitis at the time of subject screening; 6. Patients who are allergic to therapeutic drug ingredients.

Design outcomes

Primary

MeasureTime frame
blood routine;immune globulin;lymphocyte subsets;cytokines;health-related quality of life score;liver and kidney function;efficacy;bleeding score;

Countries

China

Contacts

Public ContactWu Dijiong

Zhejiang Provincial Hospital of Traditional Chinese Medicine

wdj850@163.com+86 571 86620325

Outcome results

None listed

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