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. |