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Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

RecruitingPhase 3Ages 18 Years - anyAllNational Taiwan University Hospital
NCT07265297 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Hydrochloroquine
  • Placebo
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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