The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
NCT ID: NCT06479304
Last Updated: 2024-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
129 participants
INTERVENTIONAL
2024-04-24
2026-12-31
Brief Summary
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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.
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Detailed Description
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Hydroxychloroquine (HCQ) has immune modulating role on a variety of immune cells.A clinical trial enrolled immune thrombocytopenia secondary to SLE, and ITP with positive anti-nuclear antibodiy (ANA) were treated with HCQ combined with glucocorticoids. The results showed an overall response rate of 60% (24 / 40), including 18 continuous complete response (CR) and 6 continuous response (R), and some patients had continued elevated platelet counts 3 months after treatment initiation. The above studies illustrate that HCQ contributes to the treatment of chronic ITP, especially as a long-term therapeutic agent with low economic burden and good tolerance. In conclusion, it can be seen that HCQ and prednisone have complementary mechanism of action and complementary time window, which can be used as a combination for the treatment of ITP select.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HCQ plus Pred group
This group is experiment group. Participants will take Pred every day for 6 weeks with HCQ twice a day for 1 year
Hydroxychloroquine Oral Tablet
Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.
Prednisone tablet
Prednisone is given at the dose of 1mg/kg every morning after meals for 2 weeks ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, prednisone will be given at the dose for 2 more weeks ), then tapering off.
Pred group
This group is control group. Participants will take Pred every day for 6 weeks.
Prednisone tablet
Prednisone is given at the dose of 1mg/kg every morning after meals for 2 weeks ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, prednisone will be given at the dose for 2 more weeks ), then tapering off.
Interventions
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Hydroxychloroquine Oral Tablet
Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.
Prednisone tablet
Prednisone is given at the dose of 1mg/kg every morning after meals for 2 weeks ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, prednisone will be given at the dose for 2 more weeks ), then tapering off.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The antinuclear antibody is positive.
4. Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative.
5. 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.
6. Understand the study procedures and sign the written informed consent form.
Exclusion Criteria
2. 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.
3. 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.
4. With severe hemorrhage (intracranial hemorrhage) or coagulation dysfunction (INR and APTT\> 125% upper limit of normal).
5. With severe digestive tract diseases affecting drug absorption.
6. With serious mental illness patient.
7. Having participated in other clinical trials within 3 months prior to screening.
8. Having received any immunomodulatory medication for other diseases 3 months before screening.
9. 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.
10. With Glucose-6-phosphate dehydrogenase deficiency.
11. With retinal or visual field changes caused by 4-aminoquinoline compounds.
12. Being allergic to 4-aminoquinoline compounds.
13. 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.
14. 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.
15. With liver cirrhosis or portal hypertension.
16. With evidence of malignant tumor activity, or receiving anti-tumor treatment within 5 years prior to the screening.
17. Addicted to alcohol or drugs.
18. 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).
15 Years
99 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Shanghai Jinshan Hospital
OTHER
Zhongshan Qingpu Hospital, Fudan University
UNKNOWN
Zhongshan Wusong Hospital, Fudan University
UNKNOWN
Macau University of Science and Technology Hospital
OTHER
Health and Humanity Research Centre, Hongkong
UNKNOWN
Dr. Stanley Ho Medical Foundation, Macau
UNKNOWN
Yunfeng Cheng
OTHER
Responsible Party
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Yunfeng Cheng
Professor of Institute of Clinical Science, Zhongshan Hospital
Principal Investigators
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Yunfeng Cheng
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Wusong Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Qingpu Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Health and Humanity Research Centre, Hongkong, China.
Hong Kong, , Hong Kong
Dr. Stanley Ho Medical Foundation
Macao, , Macau
University Hospital, Macau University of Science and Technology.
Macao, , Macau
Countries
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Central Contacts
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Facility Contacts
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References
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Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966.
Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
Mejdoub S, Hachicha H, Gargouri L, Feki S, Mahfoudh A, Masmoudi H. Antinuclear antibodies in children: clinical signification and diagnosis utility. Tunis Med. 2021 Octobre;99(10):980-984.
Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.
Other Identifiers
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B2024-028R2
Identifier Type: -
Identifier Source: org_study_id
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