Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

NCT07265297 | Recruiting Phase 3

• 1 other identifier: 202407082MINE
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

steatohepatitis; fatty liver; Hydroxychloroquine; Drug repurposing

Outcome Measures

Primary Outcomes (1)

• serum ALT

  Every 3 months, for 1 year

Study Arms (3)

HCQ 400mg

EXPERIMENTAL

Drug: Hydrochloroquine

HCQ 200mg

EXPERIMENTAL

Drug: Hydrochloroquine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hydrochloroquine DRUG

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.

HCQ 200mg; HCQ 400mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Tsai, Doctor

CONTACT

88623123456; fengchiaotsai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 4, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-08

Locations

TW (1)