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

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.

Conditions

• Immune Thrombocytopenia With Positive ANA Antibodies

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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Shanghai Jinshan Hospital

  collaborator OTHER

• Zhongshan Qingpu Hospital, Fudan University

  collaborator UNKNOWN

• Zhongshan Wusong Hospital, Fudan University

  collaborator UNKNOWN

• Macau University of Science and Technology Hospital

  collaborator OTHER

• Health and Humanity Research Centre, Hongkong

  collaborator UNKNOWN

• Dr. Stanley Ho Medical Foundation, Macau

  collaborator UNKNOWN

• Yunfeng Cheng

  lead OTHER

Principal Investigators

• Yunfeng Cheng · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-24

Primary Completion

2026-01-31

Completion

2026-12-31

Countries

• China
• Hong Kong
• Macau

Study Locations