Hepatitis, AutoimmuneNCT02994537
Study of the Clinical Features of Autoimmune Hepatitis
An observational study of Hepatitis, Autoimmune, run by Li Yang at 1 site in China.
Trial summary
The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Autoimmune
- What is being tested?
- Different biochemical results or pathogenesis.
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to 31 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the hospital outpatient or inpatient department, there is no geographical restrictions.
Who may be able to join
- Clinical diagnosis of autoimmune hepatitis
Who cannot join
- Other causes of liver disease, such as viral hepatitis, drug induced liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, overlap syndrome and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Li Yang, MD, +86 18980601276, yangli_hx@scu.edu.cn
Yi Shen, MM, +86 18280097412, 156450779@qq.com
About this study
The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH). At phase 1, the investigators focus on studying of the clinical characteristics of acute autoimmune hepatitis, and then will study the difference about treatment effects between acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug induced AIH have some special characteristics that may be beneficial to distinguish it with durg induced liver disease. Therefore the investigators will do some studies about drug induced AIH or other disease which maybe related to the onset of AIH.
Read the detailed description
Now this study has been researched at phase 1, the investigators focus on studying the difference between acute AIH and chronic AIH. In this phase, the investigators analysed the serum biochemical results such as ALT,AST,IgG,PT,INR and so on, and also compared the histological performance. Finally, we compared the percentages of biochemical remission in the two groups, and the time from initial treatment to biochemical remission has also been put into the analysis. Now, the investigators are preparing for submitting the manuscript of phase 1.
- Conditions
- Hepatitis, Autoimmune
- Being tested
- Different biochemical results or pathogenesis.
- Keywords
- autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis
- Medical subject headings
- Hepatitis, Autoimmune, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different biochemical results or pathogenesis.Other
Comparing the pathogenesis,clinical characteristics and treatment effects between the acute autoimmune hepatitis group and the chronic autoimmune hepatitis group. The investigators don't use special intervention.
| Study group | Role | What they receive |
|---|---|---|
| acute autoimmune hepatitis | Patients diagnosed autoimmune hepatitis(AIH) are divided into acute cohort or chronic cohort (acute-on-chronic and chronic were all included)by biochemical results, such as liver function and coagulation, then the investigators will compare the histological results, treatment effects and prognosis between the two groups. Further more, the investigators will study the pathogenesis of different forms of autoimmune hepatitis. Even more, the investigators want to explore drug induced AIH and viral hepatitis related AIH. Receives: Other: Different biochemical results or pathogenesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical remission of participants
This study is now in the phase 1, and the outcome at phase 1 is the biochemical remission of AIH patients. In details, if the participants' serum ALT,AST and IgG returned to normal, that means this participant reached the biochemical remission.
Measured: 3 years after standard immunosuppressive treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startOct 2013
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (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 Hepatitis, AutoimmuneStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Yang
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Li Yang, West China Hospital
- Investigators
- Li Yang, MD, Study director, Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994537
- Sponsor's protocol ID
- AAIH-001
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2016
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The investigators need to discuss with other participants whether or not to share data of the study.
Publications
Kessler WR, Cummings OW, Eckert G, Chalasani N, Lumeng L, Kwo PY. Fulminant hepatic failure as the initial presentation of acute autoimmune hepatitis. Clin Gastroenterol Hepatol. 2004 Jul;2(7):625-31. doi: 10.1016/s1542-3565(04)00246-0.
PubMed 15224287Fujiwara K, Nakano M, Yasui S, Okitsu K, Yonemitsu Y, Yokosuka O. Advanced histology and impaired liver regeneration are associated with disease severity in acute-onset autoimmune hepatitis. Histopathology. 2011 Apr;58(5):693-704. doi: 10.1111/j.1365-2559.2011.03790.x. Epub 2011 Mar 14.
PubMed 21401703Abe M, Hiasa Y, Masumoto T, Kumagi T, Akbar SM, Ninomiya T, Matsui H, Michitaka K, Horiike N, Onji M. Clinical characteristics of autoimmune hepatitis with histological features of acute hepatitis. Hepatol Res. 2001 Nov;21(3):213-219. doi: 10.1016/s1386-6346(01)00109-7.
PubMed 11673106Shen Y, Lu C, Men R, Liu J, Ye T, Yang L. Clinical and Pathological Characteristics of Autoimmune Hepatitis with Acute Presentation. Can J Gastroenterol Hepatol. 2018 Mar 18;2018:3513206. doi: 10.1155/2018/3513206. eCollection 2018.
PubMed 29744332
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Features of Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT02994537
- Acronym / sponsor ID
- AAIH-001
- Conditions
- Hepatitis, Autoimmune
- Keywords
- autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Li YangUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Oct 2013
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- 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.
The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH). At phase 1, the investigators focus on studying of the clinical characteristics of acute autoimmune hepatitis, and then will study the difference about treatment effects between acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug induced AIH have some special characteristics that may be beneficial to distinguish it with durg induced liver disease. Therefore the investigators will do some studies about drug induced AIH or other disease which maybe related to the onset of AIH.
Detailed description
Now this study has been researched at phase 1, the investigators focus on studying the difference between acute AIH and chronic AIH. In this phase, the investigators analysed the serum biochemical results such as ALT,AST,IgG,PT,INR and so on, and also compared the histological performance. Finally, we compared the percentages of biochemical remission in the two groups, and the time from initial treatment to biochemical remission has also been put into the analysis. Now, the investigators are preparing for submitting the manuscript of phase 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute autoimmune hepatitis | – | Other: Different biochemical results or pathogenesis.Patients diagnosed autoimmune hepatitis(AIH) are divided into acute cohort or chronic cohort (acute-on-chronic and chronic were all included)by biochemical results, such as liver function and coagulation, then the investigators will compare the histological results, treatment effects and prognosis between the two groups. Further more, the investigators will study the pathogenesis of different forms of autoimmune hepatitis. Even more, the investigators want to explore drug induced AIH and viral hepatitis related AIH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the hospital outpatient or inpatient department, there is no geographical restrictions.
Key inclusion criteria (1 listed)
- Clinical diagnosis of autoimmune hepatitis
Key exclusion criteria (1 listed)
- Other causes of liver disease, such as viral hepatitis, drug induced liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, overlap syndrome and so on.
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 |
|---|---|---|
| Different biochemical results or pathogenesis.Comparing the pathogenesis,clinical characteristics and treatment effects between the acute autoimmune hepatitis group and the chronic autoimmune hepatitis group. The investigators don't use special intervention. | Other | acute autoimmune hepatitis |
Primary outcome
Biochemical remission of participants
Time frame: 3 years after standard immunosuppressive treatment.
This study is now in the phase 1, and the outcome at phase 1 is the biochemical remission of AIH patients. In details, if the participants' serum ALT,AST and IgG returned to normal, that means this participant reached the biochemical remission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 15224287Kessler WR, Cummings OW, Eckert G, Chalasani N, Lumeng L, Kwo PY. Fulminant hepatic failure as the initial presentation of acute autoimmune hepatitis. Clin Gastroenterol Hepatol. 2004 Jul;2(7):625-31. doi: 10.1016/s1542-3565(04)00246-0.
- Results publication: PubMed 21401703Fujiwara K, Nakano M, Yasui S, Okitsu K, Yonemitsu Y, Yokosuka O. Advanced histology and impaired liver regeneration are associated with disease severity in acute-onset autoimmune hepatitis. Histopathology. 2011 Apr;58(5):693-704. doi: 10.1111/j.1365-2559.2011.03790.x. Epub 2011 Mar 14.
- Results publication: PubMed 11673106Abe M, Hiasa Y, Masumoto T, Kumagi T, Akbar SM, Ninomiya T, Matsui H, Michitaka K, Horiike N, Onji M. Clinical characteristics of autoimmune hepatitis with histological features of acute hepatitis. Hepatol Res. 2001 Nov;21(3):213-219. doi: 10.1016/s1386-6346(01)00109-7.
- Derived from this study: PubMed 29744332Shen Y, Lu C, Men R, Liu J, Ye T, Yang L. Clinical and Pathological Characteristics of Autoimmune Hepatitis with Acute Presentation. Can J Gastroenterol Hepatol. 2018 Mar 18;2018:3513206. doi: 10.1155/2018/3513206. eCollection 2018.
- Individual participant dataSharing planned: Undecided. The investigators need to discuss with other participants whether or not to share data of the study.
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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.
Li Yang, MD study director
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan 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 Hepatitis, Autoimmune, run by Li Yang at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. 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 China. 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 Li Yang, MD (+86 18980601276, yangli_hx@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical remission of participants (time frame: 3 years after standard immunosuppressive treatment.). 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 NCT02994537, 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 29 Apr 2022.