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

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ClinicalTrials.gov Identifier: NCT04594694
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Description
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Brief Summary:
Study to determine the effect of the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF) in patients with Primary Biliary Cholangitis (also known as PBC).

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Obeticholic acid Drug: Bezafibrate 200 MG Drug: OCA Placebo Drug: Bezafibrate 200 mg Placebo Drug: Bezafibrate 400 MG Drug: Bezafibrate 400 mg Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment A: BZF 200 mg IR
Bezafibrate (BZF): 200 mg IR Ocaliva (OCA) Placebo Bezafibrate (BZF) 400 mg Placebo
 Drug: Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study

Drug: OCA Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Active Comparator: Treatment B: BZF 400 mg SR
Bezafibrate (BZF): 400 mg SR Ocaliva (OCA) Placebo Bezafibrate (BZF) 200 mg Placebo
 Drug: OCA Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Experimental: Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
Ocaliva (OCA): 5 mg to 10 mg Bezafibrate (BZF) 200 mg IR Bezafibrate (BZF) 400 mg Placebo
 Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

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

Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Experimental: Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Ocaliva (OCA): 5 mg to 10 mg Bezafibrate (BZF) 400 mg SR Bezafibrate (BZF) 200 mg Placebo
 Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study

Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study


Outcome Measures
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Primary Outcome Measures :
  1. The 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 Outcome Measures :
  1. Response rates of ≥10%, ≥20%, 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 ]
  2. Reduction, response rates and normalization of biochemical disease marker Alanine Aminotransferase (ALT) [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  3. Reduction, response rates and normalization of biochemical disease marker Gamma-Glutamyl Transpeptidase (GGT) [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  4. Reduction, response rates and normalization of biochemical disease marker Aspartate Aminotransferase (AST) [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  5. Reduction, response rates and normalization of biochemical disease markers total & conjugated bilirubin [ Time Frame: Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 ]
  6. Biomarkers of bile acid synthesis, 7α hydroxy 4 cholesten-3 one (C4) and bile acids [ Time Frame: Baseline, Day 1, Weeks 2, 4, 6, 12, 24 and 48 ]
  7. Biomarkers of bile acid homeostasis and bile acids [ Time Frame: Baseline, Day 1, Weeks 2, 4, 6, 12, 24 and 48 ]
  8. Safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events [ Time Frame: Baseline, Day 1, Weeks 2, 4, 6, 12, 24 and 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A definite or probable diagnosis of PBC
  • Qualifying ALP and/or bilirubin liver biochemistry values
  • Taking 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 participation in a previous study involving OCA

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594694


Contacts
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Contact: Natasha Warner +44-203-805-7557 Natasha.Warner@InterceptPharma.com
Contact: Erminia Cafasso erminia.cafasso@interceptpharma.com

Locations
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Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
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Study Director: George Harb, M.D. Intercept Pharmaceuticals, Inc.
More Information
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Publications:

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Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04594694    
Other Study ID Numbers: 747-213
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Intercept Pharmaceuticals:
Primary Biliary Cholangitis
Primary Biliary Cirrhosis
PBC
 Hepatic Impairment
Cirrhosis
Liver
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
 Liver Cirrhosis
Fibrosis
Pathologic Processes
Bezafibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents