NCT07265297RecruitingPhase 3
Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 12 Aug 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07265297
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 210
- From 12 Aug 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.
Other illness
- Known history of hypersensitivity or severe adverse drug reaction to HCQ.
Lab values
- Active viral hepatitis, determined by serum HBV or HCV viral load.
Age
- Participants younger than 18 years old.
Other
- Pregnant or breastfeeding women.
- Presence of retinal maculopathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.