Hydroxychloroquine treatment for nonalcoholic steatohepatitis

A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

This study will test whether taking hydroxychloroquine daily for 12 months helps adults with nonalcoholic steatohepatitis and is safe.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei, Taiwan)
• Trial ID: NCT07265297 on ClinicalTrials.gov

What this trial studies

Adults with imaging-confirmed fatty liver and persistent liver inflammation (ALT > 41 IU/L) will be enrolled and assigned to daily hydroxychloroquine 400 mg, hydroxychloroquine 200 mg, or placebo for 12 months. Participants will return to the clinic every three months for safety checks and liver-related tests. The trial compares active drug versus placebo to see if hydroxychloroquine reduces signs of steatohepatitis and to monitor adverse events. The study is conducted at National Taiwan University Hospital with eligibility criteria excluding viral hepatitis, current HCQ use, pregnancy/breastfeeding, and retinal disease.

Who should consider this trial

Good fit: Adults aged 18 or older with imaging-confirmed fatty liver and ongoing liver inflammation (ALT > 41 IU/L) who can attend regular visits and do not have viral hepatitis, current HCQ use, pregnancy/breastfeeding, or retinal disease.

Not a fit: People with active HBV or HCV infection, current hydroxychloroquine use, retinal maculopathy, pregnant or breastfeeding women, or those under 18 are not eligible and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, hydroxychloroquine could reduce liver inflammation and slow progression of nonalcoholic steatohepatitis using an inexpensive, widely available oral medication.

How similar studies have performed: Hydroxychloroquine has been used in other inflammatory diseases but there is limited clinical evidence supporting benefit specifically for nonalcoholic steatohepatitis, so this is a relatively novel repurposing effort.

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.

Where this trial is running

Taipei, Taiwan

• National Taiwan University Hospital — Taipei, Taiwan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Tsai, Doctor

Conditions Steatohepatitis, Nonalcoholic; steatohepatitis; fatty liver; Hydroxychloroquine; Drug repurposing