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RECRUITING
NCT06479304
NA

The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP

Sponsor: Yunfeng Cheng

View on ClinicalTrials.gov

Summary

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: 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.

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

Key Details

Gender

All

Age Range

15 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2024-04-24

Completion Date

2026-12

Last Updated

2024-06-28

Healthy Volunteers

No

Interventions

DRUG

Hydroxychloroquine Oral Tablet

Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.

DRUG

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.

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