Clinical trials: Cholangitis
Recurrent Ascending Cholangitis After Biliary-enteric Anastomosis
Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis
This single-center prospective randomized controlled trial plans to recruit 60 adult patients with recurrent ascending cholangitis after biliary-enteric anastomosis.
- Trial name
- NCT07895433
- Testing
- Rifaximin combined with standard care, Standard Care (in control arm)
- Volunteers
- 60 people
- Sponsor
- Ruijin Hospital
Primary Sclerosing Cholangitis
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional…
- Trial name
- ELMWOOD (NCT05627362)
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 62 sites in United States, Canada and 5 more
- Volunteers
- 68 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis (PBC)
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a…
- Trial name
- ELFIDENCE (NCT06016842)
- Testing
- Elafibranor
- Where
- 198 sites in United States, Argentina and 26 more
- Volunteers
- 276 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
- Trial name
- ELFINITY (NCT06447168)
- Where
- 72 sites in United States, Australia and 9 more
- Volunteers
- 424 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC.
- Trial name
- ELONSEN (NCT06730061)
- Testing
- Elafibranor
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Ipsen
Primary Sclerosing Cholangitis
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC).
- Trial name
- ELASCOPE (NCT07387549)
- Testing
- Elafibranor
- Where
- 231 sites in United States, Argentina and 23 more
- Volunteers
- 350 people
- Sponsor
- Ipsen
Primary Sclerosing Cholangitis
Vancomycin for Primary Sclerosing Cholangitis
To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD
- Trial name
- NCT03710122
- Testing
- Vancomycin
- Where
- 4 sites in United States
- Volunteers
- 102 people
- Sponsor
- Elizabeth Carey
Primary Sclerosing Cholangitis
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible…
- Trial name
- VISTAS (NCT04663308)
- Testing
- Volixibat
- Where
- 103 sites in United States, Argentina and 12 more
- Volunteers
- 182 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Background: Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease.
- Trial name
- NCT04685200
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
Secondary Sclerosing Cholangitis
Secondary Sclerosing Cholangitis in Critically Ill Patients
SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. The investigators hypothesize that genetic variants of biliary transporter genes are frequent in patients with SSC-CIP.
- Trial name
- SSC-CIP (NCT02545309)
- Where
- Austria
- Volunteers
- 140 people
- Sponsor
- Medical University of Graz
Secondary Sclerosis Cholangitis in Critically Ill Patients
Secondary Sclerosis Cholangitis Prospective
SC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. Gut microbiome composition, gut permeability, bacterial translocation, inflammation and/or genetic variants contribute to the…
- Trial name
- SSCpro (NCT03566797)
- Where
- Austria
- Volunteers
- 380 people
- Sponsor
- Medical University of Graz
Primary Sclerosing Cholangitis, Ulcerative Colitis
Gluten-free Diet in PSC and IBD
Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries.
- Conditions
- Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract
- Trial name
- NCT06026449
- Testing
- Gluten-free diet
- Where
- Czechia
- Volunteers
- 51 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC)
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
This clinical trial tests if oral vancomycin can safely treat active ulcerative colitis (UC) in adults who also have primary sclerosing cholangitis (PSC), a liver condition.
- Trial name
- DRIVE-UP (NCT07341282)
- Testing
- Vancomycin (blinded), Vancomycin (open-label extension)
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- McMaster University
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Primary Biliary Cholangitis
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis.
- Trial name
- AFFIRM (NCT06051617)
- Testing
- Seladelpar
- Where
- 217 sites in United States, Argentina and 27 more
- Volunteers
- 402 people
- Sponsor
- Gilead Sciences
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to…
- Trial name
- NCT06553768
- Testing
- Maralixibat
- Where
- 23 sites in United States, Brazil and 8 more
- Volunteers
- 90 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
- Conditions
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis, Cholestasis
- Trial name
- NCT07843420
- Testing
- Nemolizumab-ilto
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis, Inflammatory Bowel Diseases
FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.
- Trial name
- FARGO (NCT06286709)
- Testing
- Faecal Microbiota Transplant
- Where
- 5 sites in United Kingdom
- Volunteers
- 58 people
- Sponsor
- University of Birmingham