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

ConditionsHepatitis B Virus Steatosis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

In this study, the investigators aimed to evaluate the hepatoprotective effect of OCA against HBV-induced liver injury by comparing patients demographic , laboratory date ( liver function , viremia ) , degree of hepatic steatosis and fibrosis and portal doppler at the beginning and after six months .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

patients under the age of 18.

patients with other viral hepatitis infection .

Hepatocellular carcinoma .

portal vein thrombosis.

Trial design

Design model

Parallel

Treatments tested in this trial

Obeticholic Acid 5 mg
Drug
\- Patients will be randomly divided into two groups , the first will receive obeticholic acid at a dose of 5 mg once daily and antiviral drug ,and the other will receive the antiviral drug only for six months

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: the group will receive obeticholic acidExperimental treatment 1 intervention

Group B: the group will not receive obeticholic acidNo intervention 0 interventions

Trial outcomes

Primary outcomes

Degree of hepatic steatosis before and after six months of obeticholic acid use

comparing result of fibroscan regarding degree of steatosis ,controlled attenuation parameter (CAP) which assess amount of steatosis, before and after six months of using obeticholic acid

Time frame

6 months

Secondary outcomes

portal vein doppler assesment

assesment of portal vein doppler before and after six months of obeticholic acid for evaluating : Portal vein flow direction and portal vein diameter : the direction of portal blood flow is shown by color Doppler, indicating if it is toward (hepatopetal) or away from the liver (hepatofugal). and the diameter is measured from the hilar segment when crossing the inferior vena cava while the patient is in the recumbent supine position. It is recorded in millimetres normal value \<13 mm diameter.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: