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Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

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ClinicalTrials.gov Identifier: NCT02874586
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaoli Fan, West China Hospital

Brief Summary:
An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).

Condition or disease Intervention/treatment Phase
Hepatitis, Autoimmune Other: Plasma exchange combination of immunosuppressive regimens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
Study Start Date : December 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Plasma exchange combination of immunosuppressive regimens
Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis
Other: Plasma exchange combination of immunosuppressive regimens



Primary Outcome Measures :
  1. Percent of patients that achieve biochemical remission of AIH [ Time Frame: Month 6 after the treatment initiated ]

Secondary Outcome Measures :
  1. Alanine transaminase (ALT) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  2. Aspartate transaminase(AST) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  3. Globin(GLB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  4. Immunoglobulin G(IgG) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  5. Total bilirubin(TB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  6. Direct bilirubin(DB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
  • High levels of total bilirubin (TB) (≥10 X ULN);
  • High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
  • Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

  • The presence of hepatitis A, B, C, D, or E virus infection;

    • Patients with presence of liver cirrhosis or portal hypertension;
    • Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
    • Pregnant and breeding women;
    • Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 2500/mm3), or thrombocytopenia (platelet count < 50,000/mm3);
    • Severe disorders of other vital organs, such as severe heart failure, cancer;
    • Parenteral administration of blood or blood products within 6 months before screening;
    • Recent treatment with drugs having known liver toxicity;
    • Taken part in other clinic trials within 6 months before screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874586


Contacts
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Contact: Xiaoli Fan, MM +862885422311

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Li Yang, MD    +8618980601276    yangli_hx@scu.edu.cn   
Sponsors and Collaborators
Xiaoli Fan
Investigators
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Study Chair: Li Yang, MD West China Hospital,Chengdu, Sichuan, China
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Responsible Party: Xiaoli Fan, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT02874586    
Other Study ID Numbers: AIH-2
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs