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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06488911




Registration number
NCT06488911
Ethics application status
Date submitted
28/06/2024
Date registered
5/07/2024

Titles & IDs
Public title
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Scientific title
A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis
Secondary ID [1] 0 0
977-311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FDC tablet (OCA 5 mg + BZF 400 mg SR)

Experimental: OCA 5 mg + BZF 400 mg SR - Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.


Treatment: Drugs: FDC tablet (OCA 5 mg + BZF 400 mg SR)
Participants will be administered with FDC tablets once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants reporting adverse events (AE) and serious adverse event (SAE)
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [2] 0 0
Number of participants reporting all-cause mortality
Timepoint [2] 0 0
Up to 60 months
Secondary outcome [3] 0 0
Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant
Timepoint [3] 0 0
Up to 60 months
Secondary outcome [4] 0 0
Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation
Timepoint [4] 0 0
Up to 60 months
Secondary outcome [5] 0 0
Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score =15
Timepoint [5] 0 0
Up to 60 months

Eligibility
Key inclusion criteria
* All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
133
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Santa Fe
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Croatia
State/province [17] 0 0
Zagreb
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Králové
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czechia
State/province [20] 0 0
Plzen
Country [21] 0 0
Estonia
State/province [21] 0 0
Tartu
Country [22] 0 0
France
State/province [22] 0 0
Créteil
Country [23] 0 0
France
State/province [23] 0 0
Lille
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
Germany
State/province [25] 0 0
Hanover
Country [26] 0 0
Greece
State/province [26] 0 0
Larissa
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Daegu
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seongnam-si
Country [32] 0 0
Lithuania
State/province [32] 0 0
Vilnius
Country [33] 0 0
Netherlands
State/province [33] 0 0
Amsterdam
Country [34] 0 0
Norway
State/province [34] 0 0
Lørenskog
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
Turkey
State/province [37] 0 0
Ankara
Country [38] 0 0
Turkey
State/province [38] 0 0
Bornova
Country [39] 0 0
Turkey
State/province [39] 0 0
Istanbul
Country [40] 0 0
Turkey
State/province [40] 0 0
Sanliurfa
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Hull
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Newcastle Upon Tyne
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Intercept Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antonio Civitarese, PhD
Address 0 0
Intercept Pharmaceuticals Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06488911