Patterns and Outcome of Autoimmune Related Liver Disease
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedOctober 6, 2021
October 1, 2021
1.7 years
March 26, 2019
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of patterns of autoimmune chronic liver diseases
Evaluation of patterns of autoimmune chronic liver diseasesupport and outcome of treagent of these diseases
2013-2019
Eligibility Criteria
Patients 18-60 years old with autoimmune related chronic liver disease
You may qualify if:
- Patients that will fulfill the following criteria will be enrolled:
- Patients diagnosed as AIH According to the simplified criteria of AIH scoring
- 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.
You may not qualify if:
- All patients with chronic liver disease other than autoimmune liver disease will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospitals
Asyut, Egypt
Related Publications (6)
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.
PMID: 11851837BACKGROUNDFloreani 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.
PMID: 16984499BACKGROUNDKumagi 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.
PMID: 18462376BACKGROUNDFallatah 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.
PMID: 20339178BACKGROUNDHirschfield 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.
PMID: 21180531BACKGROUNDBogdanos 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.
PMID: 23075865BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yomna Abou Elwafa
Assiut University
- STUDY DIRECTOR
Adnan Mohamed, Lecturer
Assiut University
- STUDY DIRECTOR
Mohamed Mekky, Ass. Prof.
Assiut University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
March 26, 2019
First Posted
April 2, 2019
Study Start
August 1, 2019
Primary Completion
April 1, 2021
Study Completion
August 31, 2021
Last Updated
October 6, 2021
Record last verified: 2021-10