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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

NCT02937012.

Trial name or title Efficacy and Security of Bezafibrate in Patients with Primary Biliary Cirrhosis without Biochemical Response to Ursodeoxycholic Acid: a Randomized, Double‐blind, Placebo‐controlled Trial
Methods Randomised, double‐blind, placebo‐controlled clinical trial.
Participants People with primary biliary cholangitis (non‐responders).
Interventions Group 1: UDCA + bezafibrate.
Further details: bezafibrate 200 mg capsule every 12 hours + UDCA 13 mg/kg/day to 15 mg/kg/day for 12 months.
Group 2: UDCA + placebo.
Further details: placebo capsule (for bezafibrate 200 mg capsule) every 12 hours + UDCA 13 mg/kg/day to 15 mg/kg/day for 12 months.
Outcomes Quality of life.
Starting date October 2016.
Contact information ericlopezmendez@yahoo.com.mx
sergio_sg@hotmail.com
Notes Status: recruiting.