Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis
- Conditions
- Nonalcoholic Steatohepatitis
- Registration Number
- NCT05733897
- Lead Sponsor
- National Taiwan University Hospital
- 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®).
- Detailed Description
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®).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) during the period of one year after taking hydroxychloroquine 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Graduate Institute of Pharmacology, College of Medicine, National Taiwan University
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan