Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

November 7, 2020 updated by: Xiaoli Fan

Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoli Fan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (ESTIMATE)

August 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIH-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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