Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Phase 3RecruitingNCT07265297

National Taiwan University Hospital210 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

210

Conditions

Steatohepatitis, Nonalcoholic

Interventions

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

serum ALT

Time frame: Every 3 months, for 1 year

Central Contacts

Tsai, Doctor

CONTACT

88623123456 fengchiaotsai@ntu.edu.tw

Data from ClinicalTrials.gov

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