Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B

Launched by THE UNIVERSITY OF HONG KONG · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called empagliflozin can help prevent the worsening of liver damage in patients with chronic hepatitis B (CHB) who also have significant fibrosis or cirrhosis (scarring of the liver). Empagliflozin is an SGLT2 inhibitor, a type of drug commonly used to treat diabetes, but researchers are interested in its potential effects on liver health, regardless of whether patients have diabetes. The study will involve 108 participants who will receive either empagliflozin or a placebo (a pill that looks the same but contains no active medication) for three years. The main goal is to see if empagliflozin can reduce liver stiffness, which is a sign of fibrosis progression.

To be eligible for this trial, participants need to have confirmed significant or advanced fibrosis or cirrhosis, but they cannot have certain other liver conditions, a history of liver cancer, or be pregnant. Throughout the study, participants will have regular check-ups and tests to monitor their liver health and overall well-being. This trial is important because it could provide new insights into potential treatments for liver fibrosis and cirrhosis in patients with chronic hepatitis B, a condition affecting millions worldwide.

Gender

ALL

Eligibility 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).