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RECRUITING
NCT06479317
NA

The Efficacy and Safety of HCQ Plus DEX 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 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

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

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