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NCT Number: NCT07265297

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

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

Recruiting

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Key information

Conditions

Steatohepatitis, Nonalcoholic Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Feng-Chiao Tsai

CONTACT

[email protected]

88623123456 ext. 288320

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hydrochloroquine

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. serum ALT

    Time frame: Every 3 months, for 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Tsai, Doctor

CONTACT

[email protected]

88623123456 ext. 288320

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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