NCT06691412

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

September 13, 2024

Last Update Submit

November 14, 2024

Conditions

Hepatitis B VirusSteatosis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • portal vein doppler assesment

    6 months

Study Arms (2)

the group will receive obeticholic acid

EXPERIMENTAL

The first group that will receive obeticholic acid for six months

Drug: Obeticholic Acid 5 mg

the group will not receive obeticholic acid

NO INTERVENTION

Control group

Interventions

Obeticholic Acid 5 mgDRUG

\- 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

the group will receive obeticholic acid

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Zhang L, Duan YY, Li JM, Yin JK. Hemodynamic features of Doppler ultrasonography in patients with portal hypertension: intraoperative direct measurement of portal pressure in the portal venous system. J Ultrasound Med. 2007 Dec;26(12):1689-96. doi: 10.7863/jum.2007.26.12.1689.

    PMID: 18029920BACKGROUND

  • Piscaglia F, Donati G, Serra C, Muratori R, Solmi L, Gaiani S, Gramantieri L, Bolondi L. Value of splanchnic Doppler ultrasound in the diagnosis of portal hypertension. Ultrasound Med Biol. 2001 Jul;27(7):893-9. doi: 10.1016/s0301-5629(01)00390-8.

    PMID: 11476921BACKGROUND

  • Sacerdoti D, Gaiani S, Buonamico P, Merkel C, Zoli M, Bolondi L, Sabba C. Interobserver and interequipment variability of hepatic, splenic, and renal arterial Doppler resistance indices in normal subjects and patients with cirrhosis. J Hepatol. 1997 Dec;27(6):986-92. doi: 10.1016/s0168-8278(97)80141-9.

    PMID: 9453423BACKGROUND

  • Bolognesi M, Sacerdoti D, Merkel C, Gerunda G, Maffei-Faccioli A, Angeli P, Jemmolo RM, Bombonato G, Gatta A. Splenic Doppler impedance indices: influence of different portal hemodynamic conditions. Hepatology. 1996 May;23(5):1035-40. doi: 10.1002/hep.510230515.

    PMID: 8621130BACKGROUND

  • McNaughton DA, Abu-Yousef MM. Doppler US of the liver made simple. Radiographics. 2011 Jan-Feb;31(1):161-88. doi: 10.1148/rg.311105093.

    PMID: 21257940BACKGROUND

  • Scheinfeld MH, Bilali A, Koenigsberg M. Understanding the spectral Doppler waveform of the hepatic veins in health and disease. Radiographics. 2009 Nov;29(7):2081-98. doi: 10.1148/rg.297095715.

    PMID: 19926763BACKGROUND

  • Sasso M, Miette V, Sandrin L, Beaugrand M. The controlled attenuation parameter (CAP): a novel tool for the non-invasive evaluation of steatosis using Fibroscan. Clin Res Hepatol Gastroenterol. 2012 Feb;36(1):13-20. doi: 10.1016/j.clinre.2011.08.001. Epub 2011 Sep 15.

    PMID: 21920839BACKGROUND

  • Friedrich-Rust M, Nierhoff J, Lupsor M, Sporea I, Fierbinteanu-Braticevici C, Strobel D, Takahashi H, Yoneda M, Suda T, Zeuzem S, Herrmann E. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. 2012 Feb;19(2):e212-9. doi: 10.1111/j.1365-2893.2011.01537.x. Epub 2011 Oct 30.

    PMID: 22239521BACKGROUND

  • Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.

    PMID: 18334275BACKGROUND

  • Verbeke L, Farre R, Trebicka J, Komuta M, Roskams T, Klein S, Elst IV, Windmolders P, Vanuytsel T, Nevens F, Laleman W. Obeticholic acid, a farnesoid X receptor agonist, improves portal hypertension by two distinct pathways in cirrhotic rats. Hepatology. 2014 Jun;59(6):2286-98. doi: 10.1002/hep.26939. Epub 2014 Apr 14.

    PMID: 24259407BACKGROUND

  • Erken R, Andre P, Roy E, Kootstra N, Barzic N, Girma H, Laveille C, Radreau-Pierini P, Darteil R, Vonderscher J, Scalfaro P, Tangkijvanich P, Flisiak R, Reesink H. Farnesoid X receptor agonist for the treatment of chronic hepatitis B: A safety study. J Viral Hepat. 2021 Dec;28(12):1690-1698. doi: 10.1111/jvh.13608. Epub 2021 Sep 29.

    PMID: 34467593BACKGROUND

  • GBD 2019 Hepatitis B Collaborators. Global, regional, and national burden of hepatitis B, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):796-829. doi: 10.1016/S2468-1253(22)00124-8. Epub 2022 Jun 21.

    PMID: 35738290BACKGROUND

  • Fiorucci S, Di Giorgio C, Distrutti E. Obeticholic Acid: An Update of Its Pharmacological Activities in Liver Disorders. Handb Exp Pharmacol. 2019;256:283-295. doi: 10.1007/164_2019_227.

    PMID: 31201552BACKGROUND

  • Chapman RW, Lynch KD. Obeticholic acid-a new therapy in PBC and NASH. Br Med Bull. 2020 May 15;133(1):95-104. doi: 10.1093/bmb/ldaa006.

    PMID: 32282030BACKGROUND

  • Nevens F, Andreone P, Mazzella G, Strasser SI, Bowlus C, Invernizzi P, Drenth JP, Pockros PJ, Regula J, Beuers U, Trauner M, Jones DE, Floreani A, Hohenester S, Luketic V, Shiffman M, van Erpecum KJ, Vargas V, Vincent C, Hirschfield GM, Shah H, Hansen B, Lindor KD, Marschall HU, Kowdley KV, Hooshmand-Rad R, Marmon T, Sheeron S, Pencek R, MacConell L, Pruzanski M, Shapiro D; POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med. 2016 Aug 18;375(7):631-43. doi: 10.1056/NEJMoa1509840.

    PMID: 27532829BACKGROUND

  • Cao P, Gan J, Wu S, Hu Y, Xia B, Li X, Zeng H, Cheng B, Yu H, Li F, Si L, Huang J. Molecular mechanisms of hepatoprotective effect of tectorigenin against ANIT-induced cholestatic liver injury: Role of FXR and Nrf2 pathways. Food Chem Toxicol. 2023 Aug;178:113914. doi: 10.1016/j.fct.2023.113914. Epub 2023 Jun 20.

    PMID: 37348807BACKGROUND

MeSH Terms

Conditions

Hepatitis BFatty Liver

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Mahmoud Ali Mahmoud, Professor

    Assiut University

    STUDY CHAIR

  • Baha Osman Taha, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

misheal melad fekry, Assistant Lecturer

CONTACT

0201283888183mesho0js@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of internal medicine

Study Record Dates

First Submitted

September 13, 2024

First Posted

November 15, 2024

Study Start

November 15, 2024

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

November 15, 2024

Record last verified: 2024-11