Clinical trials: Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159
The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and…
- Trial name
- NCT05082779
- Testing
- CS0159
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Autoimmune Liver Disease, Liver Transplant Disorder
A Study of SIPLIZUMAB in AILD and LT Patients
There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including…
- Conditions
- Autoimmune Liver Disease, Liver Transplant Disorder, Autoimmune Hepatitis, Primary Sclerosing Cholangitis
- Trial name
- SET-SAIL (NCT06455280)
- Testing
- Siplizumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Elizabeth C. Verna
Primary Sclerosing Cholangitis
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. There is no curative treatment for this disorder.
- Trial name
- NCT02605213
- Testing
- Vancomycin
- Where
- Iran
- Volunteers
- 30 people
- Sponsor
- Tehran University of Medical Sciences
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
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 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
Sclerosing Cholangitis
Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02424175
- Testing
- Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Brigham and Women's Hospital
Primary Sclerosing Cholangitis (PSC), Inflammatory Bowel Disease (IBD)
Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT)…
- Trial name
- FMT-SCLER (NCT07477782)
- Testing
- Fecal microbiota transplantation (FMT)
- Where
- France
- Volunteers
- 72 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Sclerosing Cholangitis (PSC)
Genomics of Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play…
- Trial name
- NCT01161992
- Testing
- Genetic Analysis
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Mayo Clinic
Hepatobiliary Diseases
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases.
- Trial name
- NCT01200082
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Primary Sclerosing Cholangitis, Cholangiocarcinoma
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy).
- Trial name
- PSC (NCT03041662)
- Testing
- MR/MRCP
- Where
- Sweden
- Volunteers
- 620 people
- Sponsor
- Karolinska University Hospital
Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC)
Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
The purpose of the registry is to know the status of primary biliary colgantis, autoimmune hepatitis, primary sclerosing cholagitis and genetic cholestatic diseases in Spain.
- Conditions
- Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Cholestatic Genetic Diseases
- Trial name
- ColHai (NCT06767605)
- Where
- Spain
- Volunteers
- 5,000 people
- Sponsor
- Asociación Española para el Estudio del Hígado
Primary Sclerosing Cholangitis
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis
- Trial name
- NCT04480840
- Testing
- PLN-74809
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 121 people
- Sponsor
- Pliant Therapeutics, Inc.
Secondary Sclerosing Cholangitis
Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)
This is a randomized, open-label, controlled, parallel group, multicenter clinical trial. Patients with confirmed secondary sclerosing cholangitis (SSC-CIP) will be randomized either in the intervention group undergoing scheduled…
- Trial name
- BISCIT (NCT05396755)
- Testing
- Endoscopic retrograde cholangiography (ERC)
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Hannover Medical School
Primary Sclerosing Cholangitis, Compensated Cirrhosis
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
- Trial name
- NCT04060147
- Testing
- Cilofexor
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Gilead Sciences
Cholangitis, Sclerosing, PSC
Swiss Primary Sclerosing Cholangitis Cohort Study
Research project in which biological material is sampled and health-related personal data is further used and collected. Coded data are used.
- Conditions
- Cholangitis, Sclerosing, PSC, Primary Sclerosing Cholangitis (PSC)
- Trial name
- NCT03146936
- Where
- 21 sites in Switzerland
- Volunteers
- 120 people
- Sponsor
- Fondazione Epatocentro Ticino
Cholangitis, Sclerosing
Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
OBJECTIVES: I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
- Trial name
- NCT00004762
- Testing
- cladribine
- Volunteers
- 5 people
- Sponsor
- National Center for Research Resources (NCRR)
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
Ulcerative Colitis, Primary Sclerosing Cholangitis
The Effects of Bromelain Supplement in Patients With Ulcerative Colitis
In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.
- Trial name
- NCT06351696
- Testing
- Bromlein
- Where
- Iran
- Volunteers
- 52 people
- Sponsor
- National Nutrition and Food Technology Institute
Primary Sclerosing Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT02943460
- Testing
- Cilofexor
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences