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Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

NCT ID: NCT02874586

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatitis, Autoimmune

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasma exchange combination of immunosuppressive regimens

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

Group Type EXPERIMENTAL

Plasma exchange combination of immunosuppressive regimens

Intervention Type OTHER

Interventions

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Plasma exchange combination of immunosuppressive regimens

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiaoli Fan

OTHER

Sponsor Role lead

Responsible Party

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Xiaoli Fan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Yang, MD

Role: STUDY_CHAIR

West China Hospital,Chengdu, Sichuan, China

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoli Fan, MM

Role: CONTACT

Phone: +862885422311

Facility Contacts

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Li Yang, MD

Role: primary

Other Identifiers

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AIH-2

Identifier Type: -

Identifier Source: org_study_id