Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

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

Study Overview

• Status: Recruiting
• Conditions: Steatohepatitis, Nonalcoholic
• Intervention / Treatment: Drug: Hydrochloroquine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tsai, Doctor; Phone Number: 288320 88623123456; Email: fengchiaotsai@ntu.edu.tw

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Feng-Chiao Tsai; Phone Number: 288320 88623123456; Email: fengchiaotsai@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: HCQ 400mg	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.
Experimental: HCQ 200mg	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum ALT	Every 3 months, for 1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: fatty liver; Hydroxychloroquine; Drug repurposing; steatohepatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 202407082MINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No