Hydroxychloroquine treatment for nonalcoholic steatohepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Taiwan University Hospital
  Taipei, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Tsai, Doctor
• Email: fengchiaotsai@ntu.edu.tw
• Phone: 88623123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.