Using hydroxychloroquine to treat liver inflammation in patients with fatty liver disease

Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

This study is testing if hydroxychloroquine can help reduce liver inflammation in people with fatty liver disease.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 2 sites (Taipei and 1 other locations)
• Trial ID: NCT05733897 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the effects of hydroxychloroquine on patients diagnosed with nonalcoholic steatohepatitis (NASH), a serious liver condition. By reviewing medical records of out-patient-clinic patients who have been treated with hydroxychloroquine, the study will assess changes in liver inflammation and metabolic profiles. The study will focus on patients who meet specific criteria related to liver health and treatment history. The goal is to gather data that could provide insights into the potential therapeutic benefits of hydroxychloroquine for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with nonalcoholic steatohepatitis who have been treated with hydroxychloroquine.

Not a fit: Patients without a diagnosis of nonalcoholic steatohepatitis or those not treated with hydroxychloroquine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from nonalcoholic steatohepatitis.

How similar studies have performed: While there is limited data on hydroxychloroquine for NASH, other studies have explored its effects on metabolic disorders, indicating potential but unproven benefits.

Eligibility criteria

screen out our targeted group：patients with nonalcoholic steatohepatitis

1. The investigators have made a request to Information Technology Office of National Taiwan University Hospital, and this request is about the list of our out-patient-clinic patients who accept the treatment of hydroxychloroquine.
2. Collect and review the medical records, ultrasound and blood tests of patients in the abovementioned list and screen out those with nonalcoholic steatohepatitis based on the following criteria.

Inclusion criteria： Our patients who taking hydroxychloroquine and match the following criteria

A. Patients with fatty liver, based on the abdominal ultrasound report of which the date is the closest to the initial date of using HCQ.

B. Alanine aminotransferase (ALT) level of 2.5 and 0.5 month prior to hydroxychloroquine treatment \> 41 U/L

C. With ALT result which is tested in 3 months after using HCQ.

D. The initial date of taking HCQ is prior to September, 26, 2022, which is the date we got the list from Information Technology Office of National Taiwan University Hospital.

Exclusion criteria： Our exclusion criteria can be separated into loose exclusion criteria and strict exclusion criteria.

Loose exclusion criteria：patients who match the following criteria will be excluded from the above group.

A. Diseases of the biliary tract：the abdominal ultrasound report indicated the patient with stones in the biliary tract, or the patient with jaundice or his total bilirubin \> 2.0 mg/dl

B. Viral hepatitis： Hepatitis B Virus (HBV) Viral Load + or Hepatitis C Virus (HCV) Viral Load +

C. Alcoholic steatohepatitis： History of drinking alcohol or aspartate aminotransferase /alanine aminotransferase (AST/ALT) \> 1.5 and γ-glutamyltransferase (GGT) \> two times of normal levels (2X)

D. Autoimmune hepatitis： anti-nuclear antibody (ANA)1:80+ (above) or mitochondrial antibody (AMA) + or liver kidney microsome antibody (anti-LKM) + or smooth muscle antibody (anti-SMA) +

E. Wilson's disease：ceruloplasmin \< 20 mg/dl

Strict exclusion criteria：patients who had ever had viral hepatitis or was being infected by virus (HBV, HCV infection：hepatitis B surface antigen positive (HBsAg+) or hepatitis B core antibody positive (HBc stands for hepatitis B core antigen, anti-HBc+ stands for hepatitis B core antibody) or anti-HCV Ab+) will be further excluded from the above group.

The definition of months：used in the criteria evaluation and the data analysis

Before patients used HCQ：

negative 0.5 month：During the periods from one month prior to the date of initial use of HCQ to that date, we define the date which is the closest to 0.5 month as -0.5 month.

negative 2.5 months：During the periods from four months to one month prior to the date of initial use of HCQ, we define the date which is the closest to 2.5 months as -2.5 months.

negative 5.5 months：During the periods from seven months to four months prior to the date of initial use of HCQ, we define the date which is the closest to 5.5 months as -5.5 months.

After patients used HCQ： 0.75 months：During the periods that patients used HCQ for 0-1.5 months, we define the date which is the closest to 0.75 months as 0.75 months.

3 months：During the periods that patients used HCQ for 1.5-4.5 months, we define the date which is the closest to 3 months as 3 months.

6 months：During the periods that patients used HCQ for 4.5-7.5 months, we define the date which is the closest to 6 months as 6 months.

9 months：During the periods that patients used HCQ for 7.5-10.5 months, we define the date which is the closest to 9 months as 9 months.

12 months：During the periods that patients used HCQ for 10.5-13.5 months, we define the date which is the closest to 9 months as 12 months.

Then, in addition to the above-mentioned criteria, we will record the following two things separately.

The first one is hemochromatosis. Hemochromatosis may also cause hepatitis, but the prevalence of this disease in Taiwan is very low. Thus, we do not list hemochromatosis in the exclusion criteria.

The second one is drug-induced hepatitis. We do not list suspected drug-induced hepatitis in the exclusion criteria since drug-induced hepatitis may not be accurately confirmed based on our current medical records. However, if we find patients using drugs which may be related to hepatitis, we will record their information separately, including the duration of using these drugs and the ALT levels after stopping using it.

Where this trial is running

Taipei and 1 other locations

• Graduate Institute of Pharmacology, College of Medicine, National Taiwan University — Taipei, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Feng-Chiao Tsai, Doctor — Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
• Study coordinator: YAO-BIN ZHENG, Master

Conditions Nonalcoholic Steatohepatitis; Hydroxychloroquine; Nonalcoholic Fatty Liver Disease