Actively Recruiting
The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP
Led by Yunfeng Cheng · Updated on 2024-06-28
126
Participants Needed
7
Research Sites
126 weeks
Total Duration
On this page
Sponsors
Y
Yunfeng Cheng
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus thrombopoietin receptor agonists (TPO-RA) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus TPO-RA. The main questions it aims to answer are: Does HCQ plus TPO-RA raise the response rate in participants, compared to TPO-RA alone? Does HCQ plus TPO-RA prolong the response duration in participants, compared to Pred alone? Does HCQ plus TPO-RA decrease the dose of TPO-RA to maintain response in participants, compared to TPO-RA alone? What medical problems do participants have when taking HCQ plus TPO-RA? Researchers will compare HCQ plus TPO-RA with TPO-RA alone to see if HCQ plus TPO-RA works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies. Participants will: Take TPO-RA every day for no more than 24 weeks, adjust the dose of TPO-RA according to the platelet level, with or without HCQ twice a day for 1 year; Visit the clinic once every 1 weeks for the first 8 weeks, and once every 2-4 weeks in the following 10 months for checkups and tests; Keep a diary of their symptoms
CONDITIONS
Official Title
The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is above 15 years old.
- Clinical diagnosis of primary immune thrombocytopenia with platelet count less than 30 x 10⁹/L within 1 week before enrollment, or less than 50 x 10⁹/L with bleeding symptoms.
- Positive antinuclear antibody test.
- Negative for other autoantibodies including dsDNA, SSA, SSB, RNP, β2-GP, ACA, ANCA.
- Previous treatment with at least two courses of high-dose dexamethasone or standard dose prednisone with persistent low platelet counts or relapse.
- Normal prothrombin time and activated partial thrombin time within specified ranges.
- Understand study procedures and provide informed consent.
You will not qualify if you...
- Secondary thrombocytopenia caused by other diseases such as myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia, antiphospholipid syndrome, or thrombotic thrombocytopenic purpura.
- History of arterial or venous thrombosis or thrombophilia.
- Recent congestive heart disease, arrhythmias requiring medication, or prolonged QT interval.
- History of organ or bone marrow transplantation.
- Recent use of medications affecting platelet function or anticoagulants.
- Glucose-6-phosphate dehydrogenase deficiency.
- Retinal or visual field changes from 4-aminoquinoline compounds.
- Allergy to 4-aminoquinoline compounds.
- Active HIV, hepatitis B or C infection.
- Elevated liver enzymes or kidney function tests beyond specified limits.
- Liver cirrhosis or portal hypertension.
- Active cancer or recent anti-tumor treatment within 5 years.
- Pregnant, lactating, or unwilling to use effective contraception during the study and 28 days after.
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Trial Site Locations
Total: 7 locations
1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Wusong Hospital, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200094
Actively Recruiting
3
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
4
Qingpu Branch of Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201700
Actively Recruiting
5
Health and Humanity Research Centre, Hongkong, China.
Hong Kong, Hong Kong, 999077
Actively Recruiting
6
Dr. Stanley Ho Medical Foundation
Macao, Macau, 999078
Actively Recruiting
7
University Hospital, Macau University of Science and Technology.
Macao, Macau, 999078
Actively Recruiting
Research Team
L
Lili Ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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