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Recruiting NCT07265297

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Phase III Interventional Steatohepatitis, Nonalcoholic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrochloroquine, Placebo.
Who it may be relevant to
Registry conditions: Steatohepatitis, Nonalcoholic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Hydrochloroquine
    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.
  • Drug Placebo
    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 outcome measures

  • serum ALT [Time frame: Every 3 months, for 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07265297 · 202407082MINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗