Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Steatohepatitis, Nonalcoholic
In brief
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
Key facts
- Study ID
- NCT07265297
- Run by
- National Taiwan University Hospital
- People needed
- 210
- Starts
- 2025-08-12
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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