Clinical trial
Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy: a 12-month, Double-blind, Randomized, Placebo-controlled Trial With a 12-month, Double-blind, Placebo-free Extension Phase.
NCT06443606 is registered in ClinicalTrials.gov with Assistance Publique - Hôpitaux de Paris as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy: a 12-month, Double-blind, Randomized, Placebo-controlled Trial With a 12-month, Double-blind, Placebo-free Extension Phase.
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Phase
- Phase 3
- Overall status
- Recruiting
- Start date
- March 27, 2025
- Completion date
- June 1, 2029
- Enrollment
- 108 (estimated)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
bpc, non optimal response to udca