Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

NCT ID: NCT07265297

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2030-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HCQ 400mg

Group Type: EXPERIMENTAL

Hydrochloroquine

Intervention Type: 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

Group Type: EXPERIMENTAL

Hydrochloroquine

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tsai, Doctor

Role: CONTACT

fengchiaotsai@ntu.edu.tw

88623123456 ext. 288320

Facility Contacts

Feng-Chiao Tsai

Role: primary

fengchiaotsai@ntu.edu.tw

88623123456 ext. 288320

Other Identifiers

202407082MINE

Identifier Type: -

Identifier Source: org_study_id