Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Completed · Phase 2 · Has a placebo group
Conditions studied: Primary Biliary Cholangitis (PBC)
In brief
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).
Key facts
- Study ID
- NCT03124108
- Run by
- Genfit
- People needed
- 45
- Starts
- 2017-04-05
- Expected to finish
- 2018-10-31
- Last updated by the study team
- 2019-09-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have provided written informed consent
- 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
- ALP >= 1.67x upper limit of normal (ULN)
- Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
- 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.
You may not qualify if…
- History or presence of other concomitant liver diseases
- Screening creatine phosphokinase (CPK) > upper limits of normal (ULN)
- Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 ULN
- Screening total bilirubin > 2 ULN
- Screening serum creatinine > 1.5 mg/dl
- 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).
- Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
- Platelet count <150 X 10\^3/microliter
- Albumin <3.5 g/dL
- Presence of clinical complications of PBC or clinically significant hepatic decompensation
- If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Known history of human immunodeficiency virus (HIV) infection
- Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.