NCT07265297 Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
| NCT ID | NCT07265297 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Taiwan University Hospital |
| Condition | Steatohepatitis, Nonalcoholic |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 210 participants in total. It began in 2025-08-12 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07265297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Steatohepatitis, Nonalcoholic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07265297 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 210 participants.
Is NCT07265297 currently recruiting?
Yes, NCT07265297 is actively recruiting participants. Contact the research team at fengchiaotsai@ntu.edu.tw for enrollment information.
Where is the NCT07265297 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07265297 clinical trial?
NCT07265297 is sponsored by National Taiwan University Hospital. The trial plans to enroll 210 participants.