A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and Fibrosis
A Study of Elafibranor in Patients with NASH and Fibrosis
Sponsor: Genfit
Enrolling: Male and Female Patients
Study Length: 5 Years
IRB Number: AAAQ9292
U.S. Govt. ID: NCT02704403
Contact: Ava Farrell: 212-305-3839 / af3025@cumc.columbia.edu
Additional Study Information: NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Once cirrhosis has developed, the serious complications of liver disease may occur, including liver failure. NASH might also lead to liver cancer. At this time, there are no drugs approved for the treatment of NASH. Based on your medical condition, you have been diagnosed or your Study Doctor believes you are suffering from NASH. Therefore, you are being asked if you want to take part in this study. Please note that if you have no recent liver biopsy (less than 6 months prior to study entry) available in your medical history, you will have to undergo a biopsy during the screening period to take part in this study.The sponsor, GENFIT is developing a new drug, Elafibranor, for the treatment of NASH. Elafibranoris an investigational drug and has not been approved by the United States Food and Drug Administration (FDA) for the treatment of NASH.The safety and the tolerability of Elafibranor has been studied in 1192 individuals including healthy lean volunteers (549) and overweight or obese subjects (60), patients with type 2 Diabetes (12), patients with cardiometabolic disease (297) and patients with NASH (274).
This study is closed
Investigator
Julia Wattacheril, MD, MPH
Do You Qualify?
Do you have a BMI of 45 kg/m2? Yes No
Females of childbearing potential must use two forms of study acceptable methods of contraception. (Males mark "Yes") Yes No
Do you have a history of known heart failure? Yes No
Do you have Type 1 Diabetes? Yes No
Submit
Cancel
You may be eligible for this study

Place Holder




For more information, please contact:
Ava Farrell
af3025@cumc.columbia.edu
212-305-3839