Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

Phase 2TerminatedNCT04594694

Intercept Pharmaceuticals75 enrolled

Overview

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Biliary Cholangitis

Interventions

Obeticholic acidDRUG

5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

Bezafibrate 200 MGDRUG

200 mg IR tablet of Bezafibrate once daily for the remainder of the study

OCA PlaceboDRUG

One tablet daily for the remainder of the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * History or presence of other concomitant liver diseases * Clinical complications of PBC * History or presence of hepatic 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 other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (33)

Outcomes

Primary Outcomes

Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Secondary Outcomes

Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP)

Time frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12

Number of participants with normalization rates of biochemical disease marker Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), total and conjugated bilirubin and lipid panel

Time frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12

Change in GGT from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Change in ALT from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Change in AST from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Change in total and conjugated bilirubin from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Change in lipid panel from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12

Time frame: Baseline, Day 1, and Weeks 4, 8, and 12

Data from ClinicalTrials.gov

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Flinders Medical Centre

Bedford Park, Perth, Australia

Royal Adelaide Hospital

Adelaide, Australia

UZ Gasthuisberg

Leuven, Belgium

Clinical Hospital Dubrava

Zagreb, Croatia

Zagreb University Hospital Center

Zagreb, Croatia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

Artroscan s.r.o., Gastroenterologicka ambulance

Ostrava, Czechia

Research Site s.r.o.

Pilsen, Czechia

Tartu University Hospital

Tartu, Estonia

Hôpital Henri Mondor

Créteil, France

...and 23 more locations