Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

National Taiwan University

Status and phase: Enrolling; Phase 3

Conditions: Steatohepatitis, Nonalcoholic

Treatments: Drug: Placebo; Drug: Hydrochloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT07265297

202407082MINE

Details and patient eligibility

About

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 3 patient groups, including a placebo group

HCQ 400mg

Experimental group

Treatment:

Drug: Hydrochloroquine

HCQ 200mg

Experimental group

Treatment:

Drug: Hydrochloroquine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo