The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP

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

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

Eltrombopag

Participants will take eltrombopag for at least 24 weeks, the dose of eltrombopag is adjusted according to participants' platelet count.

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

2024-07-31

Primary Completion

2026-01-31

Completion

2026-12-31

Countries

• China
• Hong Kong
• Macau

Study Locations