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

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.

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

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).

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

75 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