A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Ursodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid only
West China Hospital
Chengdu, Sichuan, China
RECRUITINGBiochemical remission
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
Time frame: up to 12 months
Partial remission
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels \>1x Upper Limit of Normal (ULN) and \<2x ULN
Time frame: up to 12 months
Minimal response
Minimal response, defined as decrease of ALT or AST serum levels but still \>2x ULN
Time frame: up to 12 months
Treatment failure
defined as no improvement or increase of ALT or AST serum levels
Time frame: up to 12 months
Side-effects
Drug related side-effects
Time frame: up to 12 months
Clinical symptoms
Jaundice, fatigue, itching, etc
Time frame: up to 12 months
Changes in the proportion of blood immune cells
percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT
Time frame: up to 12 months
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