Steatohepatitis, Nonalcoholic
Conditions
Keywords
steatohepatitis, fatty liver, Hydroxychloroquine, Drug repurposing
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
Interventions
DRUGHydrochloroquine
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.
DRUGPlacebo
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
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum ALT | Every 3 months, for 1 year |
Countries
Taiwan
Contacts
Primary ContactTsai, Doctor
Outcome results
None listed