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Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Recruiting
18 years and older
All
Phase 3

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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

Eligibility

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.

Study details
    Steatohepatitis
    Nonalcoholic

NCT07265297

National Taiwan University Hospital

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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