Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
Primary Purpose
Hepatitis, Autoimmune
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plasma exchange combination of immunosuppressive regimens
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis, Autoimmune
Eligibility 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.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plasma exchange combination of immunosuppressive regimens
Arm Description
Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis
Outcomes
Primary Outcome Measures
Percent of patients that achieve biochemical remission of AIH
Secondary Outcome Measures
Alanine transaminase (ALT)
Aspartate transaminase(AST)
Globin(GLB)
Immunoglobulin G(IgG)
Total bilirubin(TB)
Direct bilirubin(DB)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02874586
Brief Title
Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
Official Title
Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoli Fan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Autoimmune
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plasma exchange combination of immunosuppressive regimens
Arm Type
Experimental
Arm Description
Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis
Intervention Type
Other
Intervention Name(s)
Plasma exchange combination of immunosuppressive regimens
Primary Outcome Measure Information:
Title
Percent of patients that achieve biochemical remission of AIH
Time Frame
Month 6 after the treatment initiated
Secondary Outcome Measure Information:
Title
Alanine transaminase (ALT)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
Title
Aspartate transaminase(AST)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
Title
Globin(GLB)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
Title
Immunoglobulin G(IgG)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
Title
Total bilirubin(TB)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
Title
Direct bilirubin(DB)
Time Frame
Day 1, and Week 1, 2, 4, 12, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Fan, MM
Phone
+862885422311
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
West China Hospital,Chengdu, Sichuan, China
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Phone
+8618980601276
Email
yangli_hx@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
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