<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02994537</url>
  </required_header>
  <id_info>
    <org_study_id>AAIH-001</org_study_id>
    <nct_id>NCT02994537</nct_id>
  </id_info>
  <brief_title>Study of the Clinical Features of Autoimmune Hepatitis</brief_title>
  <official_title>Study of the Clinical Features of Autoimmune Hepatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Li Yang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory&#xD;
      and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH).&#xD;
      At phase 1, the investigators focus on studying of the clinical characteristics of acute&#xD;
      autoimmune hepatitis, and then will study the difference about treatment effects between&#xD;
      acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug&#xD;
      induced AIH have some special characteristics that may be beneficial to distinguish it with&#xD;
      durg induced liver disease. Therefore the investigators will do some studies about drug&#xD;
      induced AIH or other disease which maybe related to the onset of AIH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Now this study has been researched at phase 1, the investigators focus on studying the&#xD;
      difference between acute AIH and chronic AIH. In this phase, the investigators analysed the&#xD;
      serum biochemical results such as ALT,AST,IgG,PT,INR and so on, and also compared the&#xD;
      histological performance. Finally, we compared the percentages of biochemical remission in&#xD;
      the two groups, and the time from initial treatment to biochemical remission has also been&#xD;
      put into the analysis. Now, the investigators are preparing for submitting the manuscript of&#xD;
      phase 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical remission of participants</measure>
    <time_frame>3 years after standard immunosuppressive treatment.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Hepatitis, Autoimmune</condition>
  <arm_group>
    <arm_group_label>acute autoimmune hepatitis</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Different biochemical results or pathogenesis.</intervention_name>
    <description>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.</description>
    <arm_group_label>acute autoimmune hepatitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and or liver tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from the hospital outpatient or inpatient department, there is no geographical&#xD;
        restrictions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of autoimmune hepatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other causes of liver disease, such as viral hepatitis, drug induced liver disease,&#xD;
             primary biliary cirrhosis, primary sclerosing cholangitis, overlap syndrome and so on.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Yang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Gastroenterology &amp; Hepatology,West China Hospital,Sichuan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Yang, MD</last_name>
    <phone>+86 18980601276</phone>
    <email>yangli_hx@scu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yi Shen, MD</last_name>
    <phone>+86 18280097412</phone>
    <email>156450779@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Gastroenterology &amp; Hepatology,West China Hospital,Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Yang, MD</last_name>
      <phone>+86 18980601276</phone>
      <email>yangli_hx@scu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yi Shen, MM</last_name>
      <phone>+86 18280097412</phone>
      <email>156450779@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yi Shen, MM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>15224287</PMID>
  </reference>
  <results_reference>
    <citation>Fujiwara 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.</citation>
    <PMID>21401703</PMID>
  </results_reference>
  <results_reference>
    <citation>Abe 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.</citation>
    <PMID>11673106</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Li Yang</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Autoimmune</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The investigators need to discuss with other participants whether or not to share data of the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02994537
org study id: AAIH-001
nct id: NCT02994537
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Biochemical remission of participants
time frame: 3 years after standard immunosuppressive treatment.
description: 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.
arm group label: acute autoimmune hepatitis
description: 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.
intervention type: Other
intervention name: Different biochemical results or pathogenesis.
description: 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.
arm group label: acute autoimmune hepatitis
serum and or liver tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Yang, MD
role: Study Director
affiliation: Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
last name: Li Yang, MD
phone: +86 18980601276
email: yangli_hx@scu.edu.cn
last name: Yi Shen, MD
phone: +86 18280097412
email: 156450779@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: 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.
PMID: 15224287
citation: Fujiwara 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.
PMID: 21401703
citation: Abe 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.
PMID: 11673106
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Li Yang
investigator title: MD
mesh term: Hepatitis A
mesh term: Hepatitis
mesh term: Hepatitis, Autoimmune
sharing ipd: Undecided
ipd description: The investigators need to discuss with other participants whether or not to share data of the study.