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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
The second hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Percentage 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
Changes in biochemical indicators compared to baseline
Changes in ALP, AST, ALT, GGT, TBIL compared to baseline
Time frame: 4,12,24,36 and 48 weeks
Assessment of the pruritus
Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Pruritus. (0-10, higher scores mean a worse outcome)
Time frame: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue
Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue. (0-10, higher scores mean a worse outcome)
Time frame: 4, 12, 24, 36, and 48 weeks
Prognostic score
The prognostic score( UK-PBC score) at 48 weeks of treatment
Time frame: 48 weeks
Prognostic score
The prognostic score( GLOBE PBC score) at 48 weeks of treatment
Time frame: 48 weeks
Changes in liver stiffness
Changes of liver stiffness measured by Fibrotouch/Fibroscan after 48 weeks of treatment
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing Second Hospital
Nanjing, Jiangsu, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Xijing Hospital
Xi'an, Shaanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shanxxi, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Peking Union Medical College Hospital
Beijing, China
...and 2 more locations
Time frame: 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase
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
Time frame: 48 weeks