Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07265297

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Led by National Taiwan University Hospital · Updated on 2025-12-04

210

Participants Needed

1

Research Sites

281 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if drug hydroxychloroquine works to treat steatohepatitis in adults. It will also learn about the safety of drug hydroxychloroquine. The main questions it aims to answer are: Does drug hydroxychloroquine improve steatohepatitis? What medical problems do participants have when taking drug hydroxychloroquine? Researchers will compare drug hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if drug hydroxychloroquine works to treat steatohepatitis. Participants will: Take drug hydroxychloroquine 400mg or hydroxychloroquine 200mg or placebo every day for 12 months Visit the clinic once every 3 months for checkups and tests

CONDITIONS

Official Title

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be at least 18 years old.
  • Participants must be able to return for scheduled follow-up visits during the 12-month study period.
  • Diagnosis of fatty liver confirmed by abdominal ultrasound or magnetic resonance imaging (MRI).
  • Evidence of liver inflammation for more than three months, shown by alanine aminotransferase (ALT) levels above 41 IU/L.
Not Eligible

You will not qualify if you...

  • Participants younger than 18 years old.
  • Pregnant or breastfeeding women.
  • Active viral hepatitis, confirmed by serum HBV or HCV viral load.
  • Currently taking hydroxychloroquine for other medical conditions.
  • History of severe allergic reaction or hypersensitivity to hydroxychloroquine.
  • Presence of retinal maculopathy.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Actively Recruiting

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Research Team

T

Tsai, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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