NCT07265297

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Steatohepatitis, Nonalcoholic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-12
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Taiwan