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A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
350 patients around the world
Available in Argentina, Brazil, United States
Ipsen
15Research sites
350Patients around the world
This study is for people with
Cholangitis
Sclerosing cholangitis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Adults participants aged 18 years or older.Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria.Compensated liver disease at screening.Stable background therapy, where applicable prior to study entry.Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.Ability to provide written informed consent and comply with study procedures.
- History or presence of other concomitant chronic liver disease.History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment.Evidence of complications of cirrhosis.Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma.Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).Administration of the following medications are prohibited as specified below.3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones.3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor.Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) >450 msec in males or QTcF >470 msec in females for participants without bundle branch block.Significant renal disease.For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women.History of alcohol abuse, or other substance abuse within 1 year prior to SV.Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.Mental instability or incompetence.Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.Medical conditions that may diminish life expectancy to <2 years.
Sites
STAT Research - CABA
Hospital Provincial del Centenario - Rosario, Santa Fe
Centro Médico GEDYT Gastroenterología Diagnóstica y Terapéutica
Hospital El Cruce - Nestor Kirchner
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Hospital Universitario Austral - Pilar
Instituto Rede D'Or de Pesquisa e Ensino - Bahia Hospital Aliança
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Instituto Americas - COI
Hospital Universitario Cassiano Antonio Moraes (HUCAM)
StudyELASCOPE
SponsorIpsen
Study typeInterventional
Conditions
Sclerosing cholangitis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07387549
