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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Tsai, Doctor
fengchiaotsai@ntu.edu.tw
88623123456
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 210
Treatments
Experimental: HCQ 400mg
Experimental: HCQ 200mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov

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