Effects of Empagliflozin on Liver Fibrosis and Cirrhosis in Chronic Hepatitis B
Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With Significant/Advanced Fibrosis or Cirrhosis: a Randomized, Double-blind Placebo-controlled Trial
This study is testing whether the medication Empagliflozin can help people with chronic hepatitis B reduce liver damage and improve liver health compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong, China) |
| Trial ID | NCT05147090 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Empagliflozin, a sodium-glucose cotransporter type-2 (SGLT2) inhibitor, on liver fibrosis and cirrhosis in patients with chronic hepatitis B. The study aims to determine whether Empagliflozin can prevent the progression of liver damage by reducing inflammation and hepatic steatosis, independent of its effects on blood sugar levels. Participants will be monitored using non-invasive techniques like magnetic resonance elastography to assess liver stiffness. The trial will compare the effects of Empagliflozin against a placebo in patients with significant fibrosis or cirrhosis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with significant or advanced fibrosis or cirrhosis confirmed by magnetic resonance elastography.
Not a fit: Patients with decompensated cirrhosis, concurrent chronic liver diseases, or contraindications to Empagliflozin will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic hepatitis B to prevent liver fibrosis and cirrhosis progression.
How similar studies have performed: While there are no randomized controlled trials specifically on SGLT2 inhibitors for chronic hepatitis B, preliminary data suggests potential benefits, indicating this approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients will be recruited if they have significant/advanced fibrosis or cirrhosis confirmed by MRE Exclusion Criteria: 1. decompensated cirrhosis (variceal bleeding, ascites, hepatic hydrothorax, hepatic encephalopathy), 2. portal vein thrombosis, 3. alcohol intake \>20g within last 2 years, 4. concurrent chronic liver disease (chronic hepatitis C infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cholangitis, drug-induced), 5. history of malignancy including hepatocellular carcinoma (HCC), 6. pregnancy, 7. contraindications to empagliflozin (estimated glomerular filtration rate (eGFR) \<45mL/min/1.73m2, recurrent genitourinary tract infections, gangrene, allergy), 8. contraindications to MRI (e.g., claustrophobia, implanted devices with ferromagnetic properties).
Where this trial is running
Hong Kong, Hong Kong, China
- The University of Hong Kong/Queen Mary Hospital — Hong Kong, Hong Kong, China, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Ka Shing Cheung, MD, MPH — The University of Hong Kong
- Study coordinator: Ka Shing Cheung, MD, MPH
- Email: cks634@hku.hk
- Phone: 22556979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.