Patterns and Outcome of Autoimmune Related Liver Disease

• ClinicalTrials.gov Identifier: NCT03898414
• Recruitment Status: Completed
• First Posted: April 2, 2019
• Last Update Posted: October 6, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Yomna Hammam Abou El-Wafa, Assiut University

Study Description

Brief Summary:

Study of the different patterns of autoimmune related chronic liver disease to assess the prevalence of various types and outcome of treatment of autoimmune related chronic liver disease

Condition or disease
Autoimmune Liver Disease

Detailed Description:

Autoimmune liver diseases (AILD) are a group of immunologically induced hepatic damage that are either hepatocellular or cholestatic. The hepatocellular forms are characterized by a significant elevation of the serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), as compared with the biliary enzymes,together with elevated serum bilirubin Autoimmune hepatitis (AIH) is the typical example of hepatocellular autoimmune liver diseases, but it can also be presented under a cholestatic pattern. Autoimmune hepatitis has a scoring diagnostic system and respond in most cases to the treatment with prednisolone and azathioprine. Primary biliary cirrhosis (PBC) is the second most common autoimmune liver diseases , with a cholestatic presentation and characterized by positive antimitochondrial antibody (AMA). It has an excellent response and long term outcome with the administration of ursodeoxycholic acid (UDCA) Another autoimmune liver disease that is thought to be a variant of PBC is the autoimmune cholangitis, being a disease that has biochemical and histological features similar to PBC; but the AMA is negative. Primary sclerosing cholangitis (PSC) is a rare entity of autoimmune liver disease that has a cholestatic presentation and respond poorly to the treatment, with the ultimate progression to advance liver cirrhosis in most patients Other forms of autoimmune liver disease include the overlap syndromes (OS), which are diseases with mixed immunological and histological patterns of two autoimmune liver disease the most commonly recognized one is AIH-PBC overlap (AIH-PSC overlap is less common). The treatment of OS involves the trial of ursodeoxycholic acid and different immunosuppressant.

The vast majority of studies examining the incidence and prevalence of autoimmune liver disease have focused on PBC. Estimates of both disease incidence and prevalence vary quite widely between studies of specific defined populations.

Primary biliary cirrhosis (PBC), autoimmune hepatitis (AIH) and primary sclerosing cholangitis (PSC) are chronic liver diseases that likely have an autoimmune basis to their pathogenesis. Although significant strides have been made in the clinical management of these conditions, their pathogenesis remains obscure. Understanding of various epidemiological factors may shed light on predisposing or causative factors of these diseases There are limited Egyptian studies available on prevalence and spectrum of autoimmune liver diseases in cholestatic liver diseases, so the investigators will design this work to evaluate the prevalence of autoimmune liver diseases in cholestatic liver diseases and clinical profile of the various autoimmune liver diseases.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Patterns and Outcome of Autoimmune Related Chronic Liver Disease : Retrospective Study
• Actual Study Start Date: August 1, 2019
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: August 31, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Evaluation of patterns of autoimmune chronic liver diseases [ Time Frame: 2013-2019 ]
   Evaluation of patterns of autoimmune chronic liver diseasesupport and outcome of treagent of these diseases

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Patients 18-60 years old with autoimmune related chronic liver disease

Criteria

-Inclusion criteria :

Patients that will fulfill the following criteria will be enrolled:

1. Patients diagnosed as AIH According to the simplified criteria of AIH scoring
2. Patients diagnosed as PBC or PSC according to the Amiracan association of study of liver disease (AASLD) - For all enrolled patients the presentation, treatment history, and outcome of treatment will be evaluated.

Exclusion criteria :

1-- All patients with chronic liver disease other than autoimmune liver disease will be excluded

Contacts and Locations

Locations

Egypt

Assiut university hospitals

Assiut, Egypt

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Yomna Abou Elwafa; Assiut University
• Study Director: Adnan Mohamed, Lecturer; Assiut University
• Study Director: Mohamed Mekky, Ass. Prof.; Assiut University

More Information

Publications:

Lee YM, Teo EK, Ng TM, Khor C, Fock KM. Autoimmune hepatitis in Singapore: a rare syndrome affecting middle-aged women. J Gastroenterol Hepatol. 2001 Dec;16(12):1384-9.

Floreani A, Niro G, Rosa Rizzotto E, Antoniazzi S, Ferrara F, Carderi I, Baldo V, Premoli A, Olivero F, Morello E, Durazzo M. Type I autoimmune hepatitis: clinical course and outcome in an Italian multicentre study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1051-7.

Kumagi T, Alswat K, Hirschfield GM, Heathcote J. New insights into autoimmune liver diseases. Hepatol Res. 2008 Aug;38(8):745-61. doi: 10.1111/j.1872-034X.2008.00366.x. Epub 2008 May 7.

Fallatah HI, Akbar HO, Qari YA. Autoimmune hepatitis: Single-center experience of clinical presentation, response to treatment and prognosis in Saudi Arabia. Saudi J Gastroenterol. 2010 Apr-Jun;16(2):95-9. doi: 10.4103/1319-3767.61235.

Hirschfield GM, Al-Harthi N, Heathcote EJ. Current status of therapy in autoimmune liver disease. Therap Adv Gastroenterol. 2009 Jan;2(1):11-28. doi: 10.1177/1756283X08098966.

Bogdanos DP, Gershwin ME. What is new in primary biliary cirrhosis? Dig Dis. 2012;30 Suppl 1:20-31. doi: 10.1159/000341118. Epub 2012 Oct 11. Review.

• Responsible Party: Yomna Hammam Abou El-Wafa, Resident, Assiut University
• ClinicalTrials.gov Identifier: NCT03898414
• Other Study ID Numbers: autoimmune liver disease
• First Posted: April 2, 2019
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases