Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

NCT05733897 | Unknown

• 1 other identifier: 202206002RINB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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®).

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Steatohepatitis; Hydroxychloroquine; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• To observe whether patients' alanine aminotransferase (ALT) levels were significantly decreased after using hydroxychloroquine (by statistically analyzing patients' ALT levels before and after using HCQ)

  Comparing patients' alanine aminotransferase (ALT) levels before using hydroxychloroquine with those after using hydroxychloroquine, to observe whether ALT levels were significantly decreased (by statistically analyzing patients' ALT levels before and after using HCQ).

  during the period of one year after taking hydroxychloroquine

Interventions

hydroxychloroquine DRUG

Using hydroxychloroquine to treat nonalcoholic steatohepatitis

Also known as: Plaquenil®

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population are collected from our out-patient-clinic patients who accept the treatment of hydroxychloroquine.

You may qualify if:

• 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 qualify 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University: collaborator

Study Sites (2)

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

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 35287643 BACKGROUND

• 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.

  PMID: 33976943 BACKGROUND

• 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.

  PMID: 28714183 BACKGROUND

• 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.

  PMID: 34104100 BACKGROUND

• 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.

  PMID: 31427967 BACKGROUND

• 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.

  PMID: 32034323 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chung-Jui Huang, Master

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

  STUDY DIRECTOR

• Feng-Chiao Tsai, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YAO-BIN ZHENG, Master

CONTACT

+886 905169559; ben24969309@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: June 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

TW (2)