The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP
NCT Number: NCT06479317
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immune Thrombocytopenia With Positive ANA Antibodies
Interventions: DRUG: Hydroxychloroquine Oral Tablet|DRUG: Dexamethasone oral
Sponsor: Yunfeng Cheng
Collaborators: Shanghai Zhongshan Hospital|Shanghai Jinshan Hospital|Zhongshan Qingpu Hospital, Fudan University|Zhongshan Wusong Hospital, Fudan University|Macau University of Science and Technology Hospital|Health and Humanity Research Centre, Hongkong|Dr. Stanley Ho Medical Foundation, Macau
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 129
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-24
Completion Date: 2026-12
Locations: Shanghai Zhongshan Hospital, Shanghai, Shanghai, 200032, China|Zhongshan Wusong Hospital, Fudan University, Shanghai, Shanghai, 200094, China|Shanghai Jinshan Hospital, Shanghai, Shanghai, 201508, China|Zhongshan Qingpu Hospital, Fudan University, Shanghai, Shanghai, 201700, China|Health and Humanity Research Centre, Hongkong, China., Hong Kong, 999077, Hong Kong|Dr. Stanley Ho Medical Foundation, Macau, 999078, Macau|University Hospital, Macau University of Science and Technology., Macau, 999078, Macau

Summary:
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.

Primary Outcome Measures: Overall response rate, The percentage of participants with platelet counts higher than 30×10\^9/L and at least twice the baseline platelet count , for at least two consecutive tests (7 days apart)., 4 weeks
Secondary Outcome Measures: Complete response rate, The percentage of participants with platelet counts higher than 100×10\^9/L , for at least two consecutive tests (7 days apart)., 1 year|Duration of response, Time from response to disease relapse (platelet count ≤ 30×10\^9/L on any test or occurance of bleeding symptoms ), 1 year|Durable response rate, Percentage of patients with complete remission lasting at least 6 months without any additional ITP-specific therapy, 1 year|Platelet count at each visit, Average platelet count at each visit, 1 year|Time to response, Time from starting treatment to response, 4 weeks|Response rate throughout the trial, The percentage of response participants (platelet counts higher than 30×10\^9/L and at least twice the baseline platelet count ) at each visit, 1 year|WHO bleeding score, WHO bleeding score at each visit, 1 year|Adverse reaction, Adverse reaction at each visit, 1 year