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Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

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

NCT07265297•National Taiwan University Hospital

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must be at least 18 years old.
•2. Participants must be able to return for scheduled follow-up visits during specific time points within the 12-month study period.
•3. Diagnosis of fatty liver confirmed by abdominal ultrasound or magnetic resonance imaging (MRI).
•4. Evidence of hepatic inflammation for more than three months, indicated by alanine aminotransferase (ALT) \> 41 IU/L.

Exclusion Criteria

•1. Participants younger than 18 years old.
•2. Pregnant or breastfeeding women.
•3. Active viral hepatitis, determined by serum HBV or HCV viral load.
•4. Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.
•5. Known history of hypersensitivity or severe adverse drug reaction to HCQ.
•6. Presence of retinal maculopathy.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Key Dates

Start Date

August 12, 2025

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2030

Last Updated

December 4, 2025

Enrollment

210

ESTIMATED participants

Conditions

Steatohepatitis, Nonalcoholic

Interventions

Hydrochloroquine

DRUG

Placebo

DRUG

Contacts

Tsai, Doctor

CONTACT

88623123456 fengchiaotsai@ntu.edu.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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