NCT03898414

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

March 26, 2019

Last Update Submit

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

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Location

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: 11851837BACKGROUND
  • 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. doi: 10.1111/j.1365-2036.2006.03104.x.

    PMID: 16984499BACKGROUND
  • 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.

    PMID: 18462376BACKGROUND
  • 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.

    PMID: 20339178BACKGROUND
  • 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.

    PMID: 21180531BACKGROUND
  • 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.

    PMID: 23075865BACKGROUND

Study Officials

  • Yomna Abou Elwafa

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Adnan Mohamed, Lecturer

    Assiut University

    STUDY DIRECTOR
  • Mohamed Mekky, Ass. Prof.

    Assiut University

    STUDY DIRECTOR

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

Locations