Actively Recruiting
TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
Led by Peking Union Medical College Hospital · Updated on 2024-06-27
56
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia (ITP) can induce immune tolerance, develop immune balance in ITP patients, and enable patients to achieve a sustained response (SRoT) after TPO-RA discontinuation.
CONDITIONS
Official Title
TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed or persistent primary ITP patients with inadequate response or relapse after first-line corticosteroid treatment with or without IVIg
- Complete response with platelet count above 100 x 10^9/L after hetrombopag treatment at doses of 2.5mg to 7.5mg per day
- Willing to participate in the study, provide informed consent, and complete all trial procedures
You will not qualify if you...
- Age over 50 years
- Contraindication to aspirin use
- Past arterial or venous thrombosis or clinical history indicating clotting disorders
- Cardiovascular risk factors such as hypertension, diabetes, or high cholesterol
- Recent (within 3 months) serious heart conditions including severe heart failure, arrhythmias, or prolonged QT interval
- Current use of anticoagulant or antiplatelet therapy
- Females receiving estrogen replacement therapy or oral contraceptives
- Current or past malignant tumors
- Secondary thrombocytopenia or other blood disorders causing low platelets
- Significant bone marrow fibrosis or other primary diseases causing thrombocytopenia
- Elevated liver enzymes or kidney function tests above specified limits
- History of liver cirrhosis or portal hypertension
- Uncontrolled infections
- Positive hepatitis B or C infection markers
- Positive HIV or syphilis antibody tests
- Known allergy to the study drug or its ingredients
- Breastfeeding, pregnant, or planning to conceive during the study
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
T
Tienan Zhu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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