Who is sponsoring NCT04751188?

NCT04751188 is sponsored by Instituto Mexicano del Seguro Social.

What condition does NCT04751188 study?

NCT04751188 studies Primary Biliary Cirrhosis.

What drugs are being tested in NCT04751188?

Interventions: Bezafibrate 200 MG Oral Tablet, Placebo, Ursodeoxycholic Acid.

What is the status of NCT04751188?

NCT04751188 is currently UNKNOWN.

Last reviewed 2021-02-09 · How we verify

Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response

NCT04751188 Phase 3 UNKNOWN

Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.

Details

Lead sponsor	Instituto Mexicano del Seguro Social
Phase	Phase 3
Status	UNKNOWN
Enrolment	11
Start date	2020-10-02
Completion	2021-07

Conditions

Primary Biliary Cirrhosis

Interventions

Bezafibrate 200 MG Oral Tablet
Placebo
Ursodeoxycholic Acid

Primary outcomes

Biochemical response — 6 months
Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.

Countries

Mexico