A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, Sichuan, China
RECRUITINGBiochemical remission
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group.
Time frame: up to 12 months
Partial remission
Partial remission, defined as ALT or 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
ALT,AST,IgG
serum ALT,AST and IgG levels
Time frame: baseline and month 3,6,12
percentage of immune cells
percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT
Time frame: baseline and month 12
Side-effects
Drug related side-effects
Time frame: up to 12 months
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