Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
NCT ID: NCT03124108
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2017-04-05
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elafibranor 80 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Elafibranor 80 mg
Two coated tablets daily for 12 weeks
Elafibranor 120 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Elafibranor 120 mg
Two coated tablets daily for 12 weeks
Placebo
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Placebo
Two coated tablets daily for 12 weeks
Interventions
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Elafibranor 80 mg
Two coated tablets daily for 12 weeks
Elafibranor 120 mg
Two coated tablets daily for 12 weeks
Placebo
Two coated tablets daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
* History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
* Positive Anti-Mitochondrial Antibodies (AMA) titers (\> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
* Liver biopsy consistent with PBC
3. ALP \>= 1.67x upper limit of normal (ULN)
4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.
Exclusion Criteria
2. Screening creatine phosphokinase (CPK) \> upper limits of normal (ULN)
3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) \> 5 ULN
4. Screening total bilirubin \> 2 ULN
5. Screening serum creatinine \> 1.5 mg/dl
6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate \[eGFR\] of less than 60 mL/min/1.73 m\^2).
7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
8. Platelet count \<150 X 10\^3/microliter
9. Albumin \<3.5 g/dL
10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
12. Known history of human immunodeficiency virus (HIV) infection
13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
18 Years
75 Years
ALL
No
Sponsors
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Genfit
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Head
Role: STUDY_DIRECTOR
Genfit
Locations
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Mayo Clinic in Arizona
Phoenix, Arizona, United States
Schiff Center for Liver Diseases
Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Piedmont Research Institute
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Northwell Health Institution
Manhasset, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Hopital Saint-Antoine
Paris, , France
Clinic for Gastroenterology and Hepatology
Cologne, , Germany
University Hospital Frankfurt
Frankfurt, , Germany
Johannes Gutenberg University
Mainz, , Germany
Liver Unit, University of Barcelona
Barcelona, , Spain
Hospital De La Sant Creu St. Pau
Barcelona, , Spain
University of Birmingham Centre for Liver Research
Birmingham, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
The Royal Liverpool University Hospital
Liverpool, , United Kingdom
King's College Hospital
London, , United Kingdom
The Newcastle Upon Tyne Hosptials NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Schattenberg JM, Pares A, Kowdley KV, Heneghan MA, Caldwell S, Pratt D, Bonder A, Hirschfield GM, Levy C, Vierling J, Jones D, Tailleux A, Staels B, Megnien S, Hanf R, Magrez D, Birman P, Luketic V. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA. J Hepatol. 2021 Jun;74(6):1344-1354. doi: 10.1016/j.jhep.2021.01.013. Epub 2021 Jan 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003817-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GFT505B-216-1
Identifier Type: -
Identifier Source: org_study_id
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