Actively Recruiting
The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
Led by Yunfeng Cheng · Updated on 2024-06-28
129
Participants Needed
7
Research Sites
135 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 prednisone (Pred) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus Pred. The main questions it aims to answer are: Does HCQ plus Pred raise the response rate in participants, compared to Pred alone? Does HCQ plus Pred prolong the response duration in participants, compared to Pred alone? What medical problems do participants have when taking HCQ plus Pred? Researchers will compare HCQ plus Pred with Pred alone to see if HCQ plus Pred works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies. Participants will: Take Pred every day for 6 weeks, with or without HCQ twice a day for 1 year , Visit the clinic once every 1 weeks for the first 4 weeks, and once every 2-4 weeks in the following 11 months for checkups and tests, Keep a diary of their symptoms.
CONDITIONS
Official Title
The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is above 75 years old, or between 15 and 75 years old with uncontrolled hypertension and diabetes mellitus, any gender
- Clinical diagnosis of primary immune thrombocytopenia before randomization
- Platelet count less than 30 x 10^9/L within 1 week before enrollment, or less than 50 x 10^9/L with bleeding symptoms within 1 week before enrollment
- Positive antinuclear antibody (ANA) test
- Negative for other autoantibodies including dsDNA, SSA, SSB, RNP, b2 2-GP, ACA, ANCA
- Prothrombin time within �b1 3 seconds of normal range, activated partial thrombin time within normal range �b1 10 seconds
- No history of coagulopathy except immune thrombocytopenia
- Understand study procedures and sign informed consent form
You will not qualify if you...
- Secondary thrombocytopenia caused by other diseases such as myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, or other causes
- History or symptoms of arterial or venous thrombosis or thrombophilia
- Recent congestive heart disease (NYHA Grade III/IV), arrhythmia requiring medication, myocardial infarction, or prolonged QTc interval
- Severe hemorrhage or coagulation dysfunction
- Severe digestive tract diseases affecting drug absorption
- Serious mental illness
- Participation in other clinical trials within 3 months prior to screening
- Use of immunomodulatory medication within 3 months before screening
- Use of medications affecting platelet function or anticoagulant therapy for over 3 consecutive days within 2 weeks before screening
- Glucose-6-phosphate dehydrogenase deficiency
- Retinal or visual field changes caused by 4-aminoquinoline compounds
- Allergy to 4-aminoquinoline compounds
- Evidence of HIV, hepatitis B or C infection
- Elevated liver enzymes or kidney function tests beyond specified limits
- Liver cirrhosis or portal hypertension
- Active malignant tumor or anti-tumor treatment within 5 years
- Alcohol or drug addiction
- Pregnancy, lactation, or unwillingness to use contraception during the trial and 28 days after trial end
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Trial Site Locations
Total: 7 locations
1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Zhongshan Wusong Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200094
Actively Recruiting
3
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
4
Zhongshan Qingpu 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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