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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

Steatohepatitis, Nonalcoholic

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

Inclusion Criteria4

  • 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 Criteria6

  • 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.

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