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Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

NCT07265297 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-12-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265297 on ClinicalTrials.gov