Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Overview

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).

Full Title of Study: “Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2019

Interventions

  • Other: Plasma exchange combination of immunosuppressive regimens

Arms, Groups and Cohorts

  • Experimental: Plasma exchange combination of immunosuppressive regimens
    • Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis

Clinical Trial Outcome Measures

Primary Measures

  • Percent of patients that achieve biochemical remission of AIH
    • Time Frame: Month 6 after the treatment initiated

Secondary Measures

  • Alanine transaminase (ALT)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24
  • Aspartate transaminase(AST)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24
  • Globin(GLB)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24
  • Immunoglobulin G(IgG)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24
  • Total bilirubin(TB)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24
  • Direct bilirubin(DB)
    • Time Frame: Day 1, and Week 1, 2, 4, 12, 24

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xiaoli Fan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Xiaoli Fan, Principal Investigator – West China Hospital
  • Overall Official(s)
    • Li Yang, MD, Study Chair, West China Hospital,Chengdu, Sichuan, China
  • Overall Contact(s)
    • Xiaoli Fan, MM, +862885422311

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