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Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

NCT05733897·2 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

YAO-BIN ZHENG, Master
CONTACT
+886 905169559 ben24969309@gmail.com

Lead

National Taiwan University Hospital

With

National Taiwan University

Nonalcoholic steatohepatitis (NASH) is a serious type of nonalcoholic fatty liver disease(NAFLD), which is characterized by lobular inflammation and apoptosis resulting from hepatic steatosis in the absence of excessive alcohol consumption. If NASH are not controlled well, it will advance to liver fibrosis, cirrhosis, and even hepatocellular carcinoma. However, there is no approved treatments currently. According to guidance of American Association for the Study of Liver Diseases (AASLD) and a few studies, vitamin E and pioglitazone are two potential pharmacologic therapies for NASH. They have some therapeutic effects; however, they also have some safety concerns. Therefore, those two drugs have not been wildly used in clinical practices. In addition to vitamin E and pioglitazone, many drugs are being tested in clinical trials. However, promising results have not been revealed yet. Recent clinical and experimental data suggested that hydroxychloroquine (HCQ) might improve metabolic profiles in patients or animals with obesity-related metabolic disorders. HCQ might also relieve liver inflammation in experimental animals with steatohepatitis. As an inhibitor of endocytosis and autophagy with therapeutic effects in autoimmune disorders, it is reasonable to speculate that HCQ might also relieve liver inflammation in patients with steatohepatitis. Therefore, HCQ has been anecdotally prescribed to patients with steatohepatitis in our clinic. Excitingly, almost all those with HCQ treatment had immediate reduction of their liver enzyme levels, indicating instant relief of their steatohepatitis. Effects of HCQ were similar in those with negative anti-nuclear antibody (ANA) compared to those with weakly positive ANA, suggesting that those are specific steatohepatitis-targeting rather than autoimmune-targeting effects from HCQ. Thus, the investigators aim to clarify whether HCQ relieves nonalcoholic steatohepatitis by reviewing medical records from our out-patient-clinic patients who accept the treatment of hydroxychloroquine (Plaquenil®).

Age

Any age

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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.
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.

You may not be if

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
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 record

StatusUnknown

PhaseNo phase

Taking part150

StartedJun 2022

UpdatedMar 2, 2023

Conditions

Nonalcoholic Steatohepatitis

Where2

Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan