Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis

UMIN ID: C000000225

Registered date:13/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Primary biliary cirrhosis
• Date of first enrollment: 2003/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention:UDCA+Bezafibrate Bezafibrate: 400mg/day for 12 months Dose of pretreatment UDCA is not changed after entry.
control:UDCA only Dose of pretreatment UDCA is not changed after entry.

Outcome(s)

• Primary Outcome: ALP, gamma-GTP
• Secondary Outcome: cytokines

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: liver diseases with other causes, such as chronic hepatitis B or C, or autoimmune hepatitis Severe renal diseases administration of steroids or glycyrrhizin within three months before entry administration of other fibrates

Related Information

• Primary Sponsor: Gunma Liver Study Group
• Source(s) of Monetary Support: Gunma Liver Study Group