Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis
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®).
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®). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03375008 -
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)
|
N/A | |
| Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT02654977 -
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
|
Phase 2 | |
| Recruiting |
NCT05211284 -
Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US
|
Phase 2 | |
| Completed |
NCT02421094 -
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
|
Phase 2 | |
| Completed |
NCT01205087 -
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
|
Phase 2 | |
| Recruiting |
NCT00152711 -
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
|
N/A | |
| Completed |
NCT02217475 -
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
|
Phase 2 | |
| Completed |
NCT04031729 -
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT03674476 -
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
|
Phase 1 | |
| Recruiting |
NCT03725631 -
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD
|
N/A | |
| Terminated |
NCT04565717 -
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 1 | |
| Completed |
NCT01679197 -
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
|
Phase 2 | |
| Active, not recruiting |
NCT05084404 -
Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease
|
Phase 2 | |
| Active, not recruiting |
NCT02574325 -
A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis
|
Phase 2 | |
| Terminated |
NCT00878592 -
Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity
|
N/A | |
| Recruiting |
NCT02148471 -
Fatty Acids, Genes and Microbiota in Fatty Liver
|
N/A | |
| Completed |
NCT00227110 -
Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
|
Phase 4 | |
| Completed |
NCT03656744 -
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
|
Phase 2 |