Working... Menu

Patterns and Outcome of Autoimmune Related Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03898414
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : July 2, 2019
Information provided by (Responsible Party):
Yomna Hammam Abou El-Wafa, Assiut University

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Patterns and Outcome of Autoimmune Related Chronic Liver Disease : Retrospective Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03898414

Layout table for location contacts
Contact: Abou Elwafa +201093265813

Sponsors and Collaborators
Assiut University
Layout table for investigator information
Principal Investigator: Yomna Abou Elwafa Assiut University
Study Director: Adnan Mohamed, Lecturer Assiut University
Study Director: Mohamed Mekky, Ass. Prof. Assiut University

Layout table for additonal information
Responsible Party: Yomna Hammam Abou El-Wafa, Resident, Assiut University Identifier: NCT03898414     History of Changes
Other Study ID Numbers: autoimmune liver disease
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases