Autoimmune HepatitisNCT06020976
Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
An observational study of Autoimmune Hepatitis, run by Sohag University at 1 site in Egypt.
Trial summary
Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure. Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- liver biobsy
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 10 Sep 2024
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * Age: under 18 years old. * Both sex. * children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis-
Who may be able to join
- Age: under 18 years old.
- Both sex.
- children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis
Who cannot join
- Patient infected with hepatitis B or C.
- Patient had autoimmune hepatitis after liver transplantation.
- Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases
Trial locations and contacts
1 site in 1 country.
Ashraf M Radwan, assistant professor contact
About this study
Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure.
Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria.
Read more
AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease.
It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.
Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.
Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease.
Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine.
Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.
- Conditions
- Autoimmune Hepatitis
- Being tested
- liver biobsy
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biobsyDiagnostic test
all pationt will be subjected yo liver biobsy to confirm diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
liver biobsy
to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation
Measured: 1 year
autoantibody
Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fathy Mohamed Abdelhakam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020976
- Sponsor's protocol ID
- soh-Med-23-07-10MS
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mieli-Vergani G, Heller S, Jara P, Vergani D, Chang MH, Fujisawa T, Gonzalez-Peralta RP, Kelly D, Mohan N, Shah U, Murray KF. Autoimmune hepatitis. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):158-64. doi: 10.1097/MPG.0b013e3181a1c265.
PubMed 19561543Maggiore G, Nastasio S, Sciveres M. Juvenile autoimmune hepatitis: Spectrum of the disease. World J Hepatol. 2014 Jul 27;6(7):464-76. doi: 10.4254/wjh.v6.i7.464.
PubMed 25067998Manns MP, Czaja AJ, Gorham JD, Krawitt EL, Mieli-Vergani G, Vergani D, Vierling JM; American Association for the Study of Liver Diseases. Diagnosis and management of autoimmune hepatitis. Hepatology. 2010 Jun;51(6):2193-213. doi: 10.1002/hep.23584. No abstract available.
PubMed 20513004Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, Lohse AW, Montano-Loza AJ. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017. doi: 10.1038/nrdp.2018.17.
PubMed 29644994
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06020976
- Acronym / sponsor ID
- soh-Med-23-07-10MS
- Conditions
- Autoimmune Hepatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure.
Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria.
AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease.
It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.
Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.
Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease.
Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine.
Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * Age: under 18 years old. * Both sex. * children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis-
Key inclusion criteria (3 listed)
- Age: under 18 years old.
- Both sex.
- children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis
Key exclusion criteria (3 listed)
- Patient infected with hepatitis B or C.
- Patient had autoimmune hepatitis after liver transplantation.
- Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver biobsyall pationt will be subjected yo liver biobsy to confirm diagnosis | Diagnostic test | – |
Primary outcome
liver biobsy
Time frame: 1 year
to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation
autoantibody
Time frame: 1 year
Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 19561543Mieli-Vergani G, Heller S, Jara P, Vergani D, Chang MH, Fujisawa T, Gonzalez-Peralta RP, Kelly D, Mohan N, Shah U, Murray KF. Autoimmune hepatitis. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):158-64. doi: 10.1097/MPG.0b013e3181a1c265.
- Background: PubMed 25067998Maggiore G, Nastasio S, Sciveres M. Juvenile autoimmune hepatitis: Spectrum of the disease. World J Hepatol. 2014 Jul 27;6(7):464-76. doi: 10.4254/wjh.v6.i7.464.
- Background: PubMed 20513004Manns MP, Czaja AJ, Gorham JD, Krawitt EL, Mieli-Vergani G, Vergani D, Vierling JM; American Association for the Study of Liver Diseases. Diagnosis and management of autoimmune hepatitis. Hepatology. 2010 Jun;51(6):2193-213. doi: 10.1002/hep.23584. No abstract available.
- Background: PubMed 29644994Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, Lohse AW, Montano-Loza AJ. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017. doi: 10.1038/nrdp.2018.17.
- Individual participant dataSharing planned: Undecided
Related trials for Autoimmune Hepatitis
RecruitingPhase 3
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Autoimmune Hepatitis, AIH
RecruitingPhase 2
Belimumab in Autoimmune Hepatitis
Autoimmune Hepatitis
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingObservational study
Thyroid Disorders in Pediatric Autoimmune Hepatitis
Thyroid Disease, Autoimmune Hepatitis
RecruitingObservational study
A-LiNK: Improving Outcomes in Autoimmune Liver Disease
Autoimmune Hepatitis, Primary Sclerosing Cholangitis
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.
Ashraf M Radwan, assistant professor contact
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 Hepatitis, run by Sohag 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fathy M abdelhahakam, resident (01270255316, fathymohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver biobsy (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06020976, which also lists 4 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 1 Sep 2023.