RecruitingPhase 3NCT07265297

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis


Sponsor

National Taiwan University Hospital

Enrollment

210 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether hydroxychloroquine (HCQ) — a medication already used for conditions like lupus and malaria — can treat fatty liver disease with inflammation (steatohepatitis). The study lasts 12 months. **You may be eligible if...** - You are 18 or older - You have been diagnosed with fatty liver disease (confirmed by ultrasound or MRI) - Your liver has shown signs of ongoing inflammation for more than 3 months (elevated liver enzyme ALT) - You can attend follow-up visits throughout the 12-month study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active viral hepatitis (hepatitis B or C) - You are already taking hydroxychloroquine for another condition - You have a known allergy or severe reaction to hydroxychloroquine - You have retinal eye disease (damage to the back of the eye) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydrochloroquine

Recruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year.

DRUGPlacebo

Recruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

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NCT07265297


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