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The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP
Sponsor: Yunfeng Cheng
Summary
The goal of this clinical trial is to learn if hydroxychloroquine (HCQ) plus thrombopoietin receptor agonists (TPO-RA) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus TPO-RA. The main questions it aims to answer are: Does HCQ plus TPO-RA raise the response rate in participants, compared to TPO-RA alone? Does HCQ plus TPO-RA prolong the response duration in participants, compared to Pred alone? Does HCQ plus TPO-RA decrease the dose of TPO-RA to maintain response in participants, compared to TPO-RA alone? What medical problems do participants have when taking HCQ plus TPO-RA? Researchers will compare HCQ plus TPO-RA with TPO-RA alone to see if HCQ plus TPO-RA works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies. Participants will: Take TPO-RA every day for no more than 24 weeks, adjust the dose of TPO-RA according to the platelet level, with or without HCQ twice a day for 1 year; Visit the clinic once every 1 weeks for the first 8 weeks, and once every 2-4 weeks in the following 10 months for checkups and tests; Keep a diary of their symptoms
Official title: The Efficacy and Safety of Hydroxychloroquine Plus TPO-RA in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-labled Clinical Trial
Key Details
Gender
All
Age Range
15 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2024-07
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.
Eltrombopag
Participants will take eltrombopag for at least 24 weeks, the dose of eltrombopag is adjusted according to participants' platelet count.
Locations (7)
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Wusong Hospital, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Jinshan Hospital
Shanghai, Shanghai Municipality, China
Qingpu Branch of Zhongshan 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