A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis

CompletadoFase 2ClinicalTrials.gov

ID: NCT05239468Tipo: INTERVENTIONALInicio: 21 de mar de 2022Fin estimado: 1 de sept de 2025

Traducción no disponible, mostrando original

Resumen

Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

A definite or probable diagnosis of PBC
Qualifying ALP and/or bilirubin liver biochemistry values
Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

Criterios de exclusión

History or presence of other concomitant liver diseases
Presence of clinical complications of PBC
History or presence of decompensating events
Current or history of gallbladder disease
If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.

Intervenciones

drug

Bezafibrate 100 mg

One tablet of bezafibrate 100 mg IR once daily

drug

Bezafibrate 200 mg

Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

drug

Obeticholic Acid 5 mg

One tablet of obeticholic acid 5 mg tablet once daily.

drug

Obeticholic Acid placebo

One tablet of obeticholic acid placebo tablet once daily

drug

Bezafibrate Placebo

One tablet of bezafibrate placebo tablet once daily

Ubicaciones

Hospital Italiano La Plata

La Plata, Buenos Aires, Argentina

DIM Clinical Privada

Ramos Mejía, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Patrocinadores

PrincipalIntercept Pharmaceuticals

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