Autoimmune Liver DiseaseNCT03898414
Patterns and Outcome of Autoimmune Related Liver Disease
An observational study of Autoimmune Liver Disease, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Liver Disease
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients 18-60 years old with autoimmune related chronic liver disease
Who may be able to join
None listed.
Who cannot join
- 1-- All patients with chronic liver disease other than autoimmune liver disease will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns and Outcome of Autoimmune Related Chronic Liver Disease : Retrospective Study
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
Read the 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.
- Conditions
- Autoimmune Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patterns of autoimmune chronic liver diseases
Evaluation of patterns of autoimmune chronic liver diseasesupport and outcome of treagent of these diseases
Measured: 2013-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Aug 2019
- Primary completion1 Apr 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Hammam Abou El-Wafa, Assiut University
- Investigators
- Yomna Abou Elwafa, Principal investigator, Assiut UniversityAdnan Mohamed, Lecturer, Study director, Assiut UniversityMohamed Mekky, Ass. Prof., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898414
- Sponsor's protocol ID
- autoimmune liver disease
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. doi: 10.1046/j.1440-1746.2001.02646.x.
PubMed 11851837Floreani 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. doi: 10.1111/j.1365-2036.2006.03104.x.
PubMed 16984499Kumagi 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.
PubMed 18462376Fallatah 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.
PubMed 20339178Hirschfield GM, Al-Harthi N, Heathcote EJ. Current status of therapy in autoimmune liver disease. Ther Adv Gastroenterol. 2009 Jan;2(1):11-28. doi: 10.1177/1756283X08098966.
PubMed 21180531Bogdanos 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.
PubMed 23075865
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Outcome of Autoimmune Related Chronic Liver Disease : Retrospective Study
- ClinicalTrials.gov ID
- NCT03898414
- Acronym / sponsor ID
- autoimmune liver disease
- Conditions
- Autoimmune Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients 18-60 years old with autoimmune related chronic liver disease
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1-- All patients with chronic liver disease other than autoimmune liver disease will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 11851837Lee 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. doi: 10.1046/j.1440-1746.2001.02646.x.
- Background: PubMed 16984499Floreani 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. doi: 10.1111/j.1365-2036.2006.03104.x.
- Background: PubMed 18462376Kumagi 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.
- Background: PubMed 20339178Fallatah 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.
- Background: PubMed 21180531Hirschfield GM, Al-Harthi N, Heathcote EJ. Current status of therapy in autoimmune liver disease. Ther Adv Gastroenterol. 2009 Jan;2(1):11-28. doi: 10.1177/1756283X08098966.
- Background: PubMed 23075865Bogdanos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yomna Abou Elwafa principal investigator
Assiut University
Adnan Mohamed, Lecturer study director
Assiut University
Mohamed Mekky, Ass. Prof. study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Liver Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of patterns of autoimmune chronic liver diseases (time frame: 2013-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898414, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.