Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis
NCT ID: NCT05733897
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2022-06-10
2025-07-01
Brief Summary
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The investigators aim to clarify whether hydroxychloroquine relieves nonalcoholic steatohepatitis by reviewing medical records from our out-patient-clinic patients who accept the treatment of hydroxychloroquine (Plaquenil®).
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Detailed Description
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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®).
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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hydroxychloroquine
Using hydroxychloroquine to treat nonalcoholic steatohepatitis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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National Taiwan University
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chung-Jui Huang, Master
Role: STUDY_DIRECTOR
Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
Feng-Chiao Tsai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
Locations
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Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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References
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Pouwels S, Sakran N, Graham Y, Leal A, Pintar T, Yang W, Kassir R, Singhal R, Mahawar K, Ramnarain D. Non-alcoholic fatty liver disease (NAFLD): a review of pathophysiology, clinical management and effects of weight loss. BMC Endocr Disord. 2022 Mar 14;22(1):63. doi: 10.1186/s12902-022-00980-1.
Niture S, Lin M, Rios-Colon L, Qi Q, Moore JT, Kumar D. Emerging Roles of Impaired Autophagy in Fatty Liver Disease and Hepatocellular Carcinoma. Int J Hepatol. 2021 Apr 22;2021:6675762. doi: 10.1155/2021/6675762. eCollection 2021.
Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
Wong SK. Repurposing New Use for Old Drug Chloroquine against Metabolic Syndrome: A Review on Animal and Human Evidence. Int J Med Sci. 2021 May 13;18(12):2673-2688. doi: 10.7150/ijms.58147. eCollection 2021.
Qiao X, Zhou ZC, Niu R, Su YT, Sun Y, Liu HL, Teng JL, Ye JN, Shi H, Yang CD, Cheng XB. Hydroxychloroquine Improves Obesity-Associated Insulin Resistance and Hepatic Steatosis by Regulating Lipid Metabolism. Front Pharmacol. 2019 Aug 2;10:855. doi: 10.3389/fphar.2019.00855. eCollection 2019.
Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7.
Other Identifiers
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202206002RINB
Identifier Type: -
Identifier Source: org_study_id
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