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Hydroxychloroquine added to prednisone for immune thrombocytopenia with positive antinuclear antibodies

Tests hydroxychloroquine plus prednisone versus prednisone alone in adults with immune thrombocytopenia.

Key facts

Who runs it
Yunfeng Cheng
Where
Hong Kong, Hong KongSee the siteAlso in 2 other countries, 6 sites
Trial code
Registry title
The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
Status
Recruiting
People taking part
129 people, planned
Started
24 Apr 2024
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Hydroxychloroquine Oral Tablet
  • Prednisone tablet
Record updated
28 June 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary immune thrombocytopenia (ITP, a low platelet count caused by the immune system) who test positive for antinuclear antibodies. It compares hydroxychloroquine plus prednisone with prednisone alone.

Age
Over 75 years. People aged 15-75 years can join only if they have uncontrolled high blood pressure and diabetes.
Sex
All sexes.
Disease stage
Primary ITP. Platelet count below 30×10^9 / L, or below 50×10^9 / L with bleeding, within 1 week before joining. Blood clotting tests must be within the limits set by the protocol.
Earlier treatment
No immune-changing medicines for other diseases in the 3 months before screening. No platelet-affecting drugs (such as aspirin, clopidogrel or NSAIDs) or blood thinners for over 3 days in a row within 2 weeks before screening.
Biomarker or test result
Antinuclear antibody positive. Other autoantibodies (such as dsDNA, SSA, SSB, RNP, β 2-GP, ACA, ANCA) must be negative.

Main reasons for not taking part

  • Low platelets caused by another disease, such as lupus or myelodysplastic syndrome
  • Past blood clots, stroke, heart attack, or serious heart disease or rhythm problems
  • HIV, hepatitis B or hepatitis C infection, or G6PD deficiency
  • Active cancer or cancer treatment within 5 years
  • Pregnant or breastfeeding, or unwilling to use effective birth control

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Age is above 75 years old, or participants with uncontrolled hypertension and diabetes mellitus at the age between 15-75 years old, gender is unlimited
  • Before randomization, the clinical diagnosis is primary immune thrombocytopenia. The platelet count is less than 30×10\^9 / L within 1 week before enrollment, or platelet count is less than 50×10\^9 / L with bleeding symptoms within 1 week before enrollment
  • The antinuclear antibody is positive
  • Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative
  • Prothrombin time does not exceed ± 3s of the normal value ranget, activated partial thrombin time is not outside normal range ± 10s; no history of coagulopathy except ITP
  • Understand the study procedures and sign the written informed consent form

Who cannot take part

  • Having participated in other clinical trials within 3 months prior to screening
  • Having received any immunomodulatory medication for other diseases 3 months before screening
  • With evidence of malignant tumor activity, or receiving anti-tumor treatment within 5 years prior to the screening
  • Addicted to alcohol or drugs
  • Secondary thrombocytopenia caused by myelodysplastic syndrome, immune diseases such as systemic lupus erythematosus, early aplastic anemia, atypical reanemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and various other causes
  • The participant has experienced any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history indicate thrombophilia
  • With severe digestive tract diseases affecting drug absorption
  • With serious mental illness patient
  • Being allergic to 4-aminoquinoline compounds
  • Having evidence of Human Immunodeficiency Virus (HIV)/ hepatitis C virus(HCV)/ hepatitis B virus(HBV) infection (HIV antibody or HCV antibody is positive, HBV surface antigen is positive, or HBV surface antigen is negative but HBV-DNA indicating viral replication
  • With liver cirrhosis or portal hypertension
  • Congestive heart disease, including New York Heart Association (NHYA) Grade III / IV, occurred within 3 months prior to screening, arrhythmia requiring medication or myocardial infarction, or arrhythmia known to increase the risk of thrombotic events (such as atrial fibrillation), or corrected QT interval (QTc) is longer than 450 ms, or QTc> 480 ms in paricipants with bundle branch block
  • With severe hemorrhage (intracranial hemorrhage) or coagulation dysfunction (INR and APTT> 125% upper limit of normal)
  • Having received any medication affecting platelet function ( Including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylates, and / or non-steroidal anti-inflammatory drugs NSAIDs ) or anticoagulant therapy for over consecutive 3 days within 2 weeks before screening
  • With Glucose-6-phosphate dehydrogenase deficiency
  • Glutamate transaminotransferase (ALT) or glutamate transaminase (AST) is higher than 1.5 times the upper limit of normal value (ULN), or total bilirubin or blood creatinine is higher than 1.2 times the ULN
  • With retinal or visual field changes caused by 4-aminoquinoline compounds
  • Participants being pregnant or lactating, or with potential fertility, reluctance to use effective contraception within the entire trial cycle and within 28 days after the end of the trial (or within 28 days after premature withdraw)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 99 years old?

Where in Hong Kong

Also in 2 other countries, 6 sites

  • Health and Humanity Research Centre, Hongkong, China.Hong Kong, Hong KongContact: Gregory ChengTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • HCQ plus Pred groupTreatment being tested

    This group is experiment group. Participants will take Pred every day for 6 weeks with HCQ twice a day for 1 year

    Treatment: Hydroxychloroquine Oral Tablet and Prednisone tablet

  • Pred groupPlacebo, for comparison

    This group is control group. Participants will take Pred every day for 6 weeks.

    Treatment: Prednisone tablet

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Efficacy and Safety of Hydroxychloroquine Plus Prednisone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-lable Clinical Trial
Plain-language title
Hydroxychloroquine added to prednisone for immune thrombocytopenia with positive antinuclear antibodiesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06479304, who can take part
Record updated
28 June 2024