Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Not Applicable

• Conditions: Hepatitis, Autoimmune

• Registration Number: NCT02874586
• Lead Sponsor: Xiaoli Fan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Study Start: 2016-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-07
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-04
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of patients that achieve biochemical remission of AIH	Month 6 after the treatment initiated

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China