Steatohepatitis, NonalcoholicPhase 3NCT07265297
Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
A Phase 3 study testing Hydrochloroquine in people with Steatohepatitis, Nonalcoholic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatohepatitis, Nonalcoholic
- What is being tested?
- Hydrochloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants younger than 18 years old.
- Pregnant or breastfeeding women.
- Active viral hepatitis, determined by serum HBV or HCV viral load.
- Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.
- Known history of hypersensitivity or severe adverse drug reaction to HCQ.
- Presence of retinal maculopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Feng-Chiao Tsai, 88623123456 ext. 288320, fengchiaotsai@ntu.edu.tw
About this study
Official title: A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
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.
Read more
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
- Conditions
- Steatohepatitis, Nonalcoholic
- Being tested
- Hydrochloroquine, Placebo
- Keywords
- steatohepatitis, fatty liver, Hydroxychloroquine, Drug repurposing
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochloroquineDrug
Recruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year.
PlaceboDrug
Recruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year.
| Study group | Role | What they receive |
|---|---|---|
| HCQ 400mg | Experimental | Not described Receives: Drug: Hydrochloroquine |
| HCQ 200mg | Experimental | Not described Receives: Drug: Hydrochloroquine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum ALT
Measured: Every 3 months, for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start12 Aug 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265297
- Sponsor's protocol ID
- 202407082MINE
- Status last verified
- Aug 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis
- ClinicalTrials.gov ID
- NCT07265297
- Acronym / sponsor ID
- 202407082MINE
- Conditions
- Steatohepatitis, Nonalcoholic
- Keywords
- steatohepatitis, fatty liver, Hydroxychloroquine, Drug repurposing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCQ 400mg | Experimental | Drug: Hydrochloroquine |
| HCQ 200mg | Experimental | Drug: Hydrochloroquine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Participants younger than 18 years old.
- Pregnant or breastfeeding women.
- Active viral hepatitis, determined by serum HBV or HCV viral load.
- Currently taking hydroxychloroquine (HCQ) for other medical conditions or indications.
- Known history of hypersensitivity or severe adverse drug reaction to HCQ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrochloroquineRecruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year. | Drug | HCQ 200mg, HCQ 400mg |
| PlaceboRecruit 210 subjects and randomly allocate them in 1:1:1 manners to three groups: HCQ 400 mg/d, HCQ 200mg/d and placebo. All subjects will receive HCQ and / or placebo for one year. | Drug | Placebo |
Primary outcome
serum ALT
Time frame: Every 3 months, for 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Steatohepatitis, Nonalcoholic
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrochloroquine in people with Steatohepatitis, Nonalcoholic, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsai, Doctor (88623123456 ext. 288320, fengchiaotsai@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum ALT (time frame: Every 3 months, for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.