Actively Recruiting
The Efficacy and Safety of HCQ Plus DEX 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 dexamethasone (DEX) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus DEX. The main questions it aims to answer are: Does HCQ plus DEX raise the response rate in participants, compared to DEX alone? Does HCQ plus DEX prolong the response duration in participants, compared to DEX alone? What medical problems do participants have when taking HCQ plus DEX? Researchers will compare HCQ plus DEX with DEX alone to see if HCQ plus DEX works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies. Participants will: Take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, take DEX every day for another consecutive 4 days) 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 DEX in ANA Positive ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is between 15 and 75 years old
- 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, β2-GP, ACA, ANCA
- Prothrombin time within ±3 seconds of normal range and activated partial thrombin time within ±10 seconds of normal range
- No history of coagulopathy except ITP
- Understanding of study procedures and signed informed consent form
You will not qualify if you...
- Secondary thrombocytopenia caused by myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia, atypical anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, or other causes
- History of arterial or venous thrombosis or clinical signs of thrombophilia
- Congestive heart disease NYHA Grade III/IV within 3 months before screening, arrhythmia requiring medication, myocardial infarction, or arrhythmia increasing thrombotic risk
- Corrected QT interval longer than 450 ms, or longer than 480 ms with bundle branch block
- Severe hemorrhage (intracranial) or coagulation dysfunction (INR and APTT > 125% upper normal limit)
- Poorly controlled hypertension or diabetes mellitus
- Severe digestive tract diseases affecting drug absorption
- Serious mental illness
- Liver cirrhosis or portal hypertension
- Evidence of malignancy or anti-tumor treatment within 5 years prior to screening
- Alcohol or drug addiction
- Participation in other clinical trials within 3 months prior to screening
- Use of immunomodulatory medications for other diseases within 3 months before screening
- Use of drugs affecting platelet function or anticoagulants for more than 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
- Infection with HIV, hepatitis B or C viruses
- Vaccination within 8 weeks before enrollment or planned during the trial
- Moderate to severe anemia (hemoglobin < 90 g/L)
- Elevated liver enzymes or bilirubin or creatinine above specified limits
- Pregnancy, lactation, or unwillingness to use effective contraception during and 28 days after the trial
AI-Screening
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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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