Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether hydroxychloroquine, a medication commonly used to treat certain autoimmune conditions, can help improve nonalcoholic steatohepatitis (NASH), a serious liver condition where fat builds up in the liver without alcohol use. NASH can lead to more severe liver problems, including liver scarring and cancer, and currently, there are no approved treatments for it. Researchers will review medical records of patients who have been treated with hydroxychloroquine to see if it has positive effects on liver health.

To be eligible for this study, participants need to have NASH and have been taking hydroxychloroquine for at least a few months. They will look at patients who have fatty liver disease as indicated by ultrasound and specific blood test results before and after starting the medication. If you or someone you know has NASH and is interested in this study, it could provide valuable information about potential treatments for this condition. Participants will be contributing to important research that aims to find better ways to manage liver health.

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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.