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

Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis - GLSG,2004,PBC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000225

Enrollment

Registered

2008-09-13

Start date

2003-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary biliary cirrhosis

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PBC (Primary Biliary Cirrhosis) with elevated ALP (more than 350IU/ml) in spite of more than 6 months administration of UDCA (ursodeoxycholic acid) and hyperlipidemia (TG>150mg/dl or T-Chol>220mg/dl)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
ALP, gamma-GTP	—

Secondary

Measure	Time frame
cytokines	—

Countries

Japan

Contacts

Public ContactKen Sato

Gunma University Graduate School of Medicine Department of Medicine and Molecular Science

satoken@showa.gunma-u.ac.jp027-220-8127

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026