Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Hepatitis, Autoimmune Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874586
• Other study ID #: AIH-2
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 2021

Study information

• Verified date: November 2020
• Source: West China Hospital
• Contact: Xiaoli Fan, MM
• Phone: +862885422311
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Other:
• Plasma exchange combination of immunosuppressive regimens

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoli Fan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients that achieve biochemical remission of AIH		Month 6 after the treatment initiated
Secondary	Alanine transaminase (ALT)		Day 1, and Week 1, 2, 4, 12, 24
Secondary	Aspartate transaminase(AST)		Day 1, and Week 1, 2, 4, 12, 24
Secondary	Globin(GLB)		Day 1, and Week 1, 2, 4, 12, 24
Secondary	Immunoglobulin G(IgG)		Day 1, and Week 1, 2, 4, 12, 24
Secondary	Total bilirubin(TB)		Day 1, and Week 1, 2, 4, 12, 24
Secondary	Direct bilirubin(DB)		Day 1, and Week 1, 2, 4, 12, 24