The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGPercentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Time frame: 48 weeks
Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks.
Time frame: 4, 12, 24 and 36weeks
Assessment of the pruritus and fatigue
Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatinine
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase Blood urea nitrogen
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatine kinase
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase ALT and AST.
Time frame: 4, 12, 24, 36, and 48 weeks
Survival without transplantation and hepatic impairment
Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death.
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGXijing Hospital
Xi'an, Shaanxi, China
RECRUITINGYan'an University Affiliated Hospital
Yan’an, Shaanxi, China
RECRUITINGSichuan Provincial People's Hospital
Chengdu, Sichuan, China
RECRUITINGTianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
RECRUITING...and 2 more locations
Time frame: 48 weeks