NCT02874586

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4.3 years

First QC Date

August 17, 2016

Last Update Submit

November 7, 2020

Conditions

Hepatitis, Autoimmune

Outcome Measures

Primary Outcomes (1)

  • Percent of patients that achieve biochemical remission of AIH

    Month 6 after the treatment initiated

Secondary Outcomes (6)

  • Alanine transaminase (ALT)

    Day 1, and Week 1, 2, 4, 12, 24

  • Aspartate transaminase(AST)

    Day 1, and Week 1, 2, 4, 12, 24

  • Globin(GLB)

    Day 1, and Week 1, 2, 4, 12, 24

  • Immunoglobulin G(IgG)

    Day 1, and Week 1, 2, 4, 12, 24

  • Total bilirubin(TB)

    Day 1, and Week 1, 2, 4, 12, 24

  • +1 more secondary outcomes

Study Arms (1)

Plasma exchange combination of immunosuppressive regimens

EXPERIMENTAL

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

Other: Plasma exchange combination of immunosuppressive regimens

Interventions

Plasma exchange combination of immunosuppressive regimensOTHER
Plasma exchange combination of immunosuppressive regimens

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Li Yang, MD

    West China Hospital,Chengdu, Sichuan, China

    STUDY CHAIR

Central Study Contacts

Xiaoli Fan, MM

CONTACT

+862885422311

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

December 1, 2016

Primary Completion

April 1, 2021

Study Completion

September 1, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CN(1)