Tests hydroxychloroquine for fatty liver inflammation in adults with steatohepatitis
Tests hydroxychloroquine against a placebo in adults with nonalcoholic steatohepatitis.
Plain-language title generated from the registry record
Registry title: Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
Key facts
- Where
- Taipei, TaiwanSee the site
- Phase
- Phase 3
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT07265297
- Record updated
- 4 December 2025
- Original description
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:Read full original descriptionShow less
A Randomized Controlled Trial of 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
Inclusion: 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: Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications; Known history of hypersensitivity or severe adverse drug reaction to HCQ; Active viral hepatitis, determined by serum HBV or HCV viral load; Participants younger than 18 years old; Pregnant or breastfeeding women; Presence of retinal maculopathy.