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RECRUITING
NCT06479291
NA

The Efficacy and Safety of HCQ Plus TPO-RA 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 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

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

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