Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes

Launched by ASSIUT UNIVERSITY · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Obeticholic Acid (OCA) to see how well it can protect the liver in patients with chronic Hepatitis B Virus (HBV) and a condition known as hepatic steatosis, which is the buildup of fat in the liver. The researchers will compare various health measurements, like liver function and the amount of fat in the liver, before and after six months of treatment. This study aims to find out if OCA can improve liver health in these patients.

To participate in the trial, individuals must be 18 years or older and have been diagnosed with chronic HBV. They should also have a specific measurement of liver fat that is above a certain level. However, those under 18, with other types of hepatitis, certain liver diseases, or significant health issues like obesity (a Body Mass Index over 35) cannot join. Participants can expect to have their liver health closely monitored throughout the study, helping researchers understand the potential benefits of OCA for liver protection in HBV patients. This trial is not yet recruiting participants, but it is an important step toward improving treatment options for those affected by HBV and liver fat buildup.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18 years of age or older who had diagnosed as chronic HBV on treatment with with Controlled Attenuation Parameter (CAP) value more than 238 dB/m .
• Exclusion Criteria:
• • patients under the age of 18.
• • patients with other viral hepatitis infection .
• • Hepatocellular carcinoma .
• • portal vein thrombosis.
• • Subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications).
• • history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis).
• • Body Mass Index (BMI) \> 35 (to avoid the possibility of Fibroscan failure).
• • Patient with end organ disease.