Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
ConditionSteatohepatitis, Nonalcoholic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrochloroquine
DrugRecruit 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
DrugRecruit 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.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: HCQ 400mgExperimental treatment 1 intervention
Group B: HCQ 200mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
serum ALT
Time frame
Every 3 months, for 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov