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

Primary Biliary Cholangitis Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04594694
• Other study ID #: 747-213
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2, 2019
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Intercept Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
• Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
• OCA Placebo
One tablet daily for the remainder of the study
• Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
• Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
• Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
• OCA
OCA one tablet will be administered.
• Bezafibrate
Bezafibrate one tablet will be administered.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Flinders Medical Centre	Bedford Park	Perth
Belgium	UZ Gasthuisberg	Leuven
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	Zagreb University Hospital Center	Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Artroscan s.r.o., Gastroenterologicka ambulance	Ostrava
Czechia	Research Site s.r.o.	Plzen
Estonia	Tartu University Hospital	Tartu
France	Hôpital Henri Mondor	Créteil
France	Centre Hospitalier Universitaire Grenoble	Grenoble
France	CHRU de Lille	Lille
France	CHU Paris Est - Hopital Saint Antoine	Paris
France	Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris	Paris
Germany	Universitatsklinikum Hamburg-Eppendorf UKE	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Greece	Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa	Larissa
Hungary	Budai Hepatologiai Centrum (BHC)	Budapest
Hungary	DEOEC II. sz. Belgyógyászati Klinika	Debrecen
Israel	Hadassah Ein-Karem Medical Center - Liver unit	Jerusalem
Israel	Tel Aviv Surasky Medical Center	Tel Aviv
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Lithuania	Hospital of Lithuanian University of Health Sciences, Kauno Klinikos	Kaunas
Lithuania	Vlinius University	Vilnius
Netherlands	Academisch Medisch Centrum	Amsterdam
Norway	Universitetet i Oslo - Akershus Universitetssykehus (AHUS)	Loerenskog
Poland	Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej	Warszawa
Spain	Fundacio Clinic Per La Recerca Biomedica	Barcelona
Spain	Consorcio Hospital General Universitario	Valencia
United Kingdom	Hull University Teaching Hospitals NHS Trust	Hull
United Kingdom	Institute of Cellular Medicine, Newcastle University	Newcastle Upon Tyne
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Intercept Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Croatia,  Czechia,  Estonia,  France,  Germany,  Greece,  Hungary,  Israel,  Korea, Republic of,  Lithuania,  Netherlands,  Norway,  Poland,  Spain,  United Kingdom, 

References & Publications (2)

European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available. — View Citation

Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Response rates of =10%, =20%, =30% and =40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP)		Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12
Secondary	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		Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12
Secondary	Change in GGT from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in ALT from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in AST from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in total and conjugated bilirubin from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in lipid panel from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in 7 alpha (a) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12		Baseline, Day 1, and Weeks 4, 8, and 12
Secondary	Change in bile acid from baseline to Week 12		Baseline, Day 1, and Weeks 4,8, and 12