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The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP
Sponsor: Yunfeng Cheng
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.
Official title: The Efficacy and Safety of Hydroxychloroquine Plus Dexamethasone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-labled Clinical Trial
Key Details
Gender
All
Age Range
15 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2024-04-24
Completion Date
2026-12
Last Updated
2024-06-28
Healthy Volunteers
No
Interventions
Hydroxychloroquine Oral Tablet
Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.
Dexamethasone oral
Dexamethasone is given at 40mg every morning after meals for 4 consecutive days( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, dexamethasone is given 40mg every day for another consecutive 4 days).
Locations (7)
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