Clinical trials: Primary Biliary Cholangitis
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Primary Sclerosing Cholangitis
Trial of High-dose Urso in Primary Sclerosing Cholangitis
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT00059202
- Testing
- Ursodeoxycholic Acid
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Liver Cirrhosis, Biliary
SAMe to Treat Biliary Cirrhosis Symptoms
This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver.
- Trial name
- NCT00125281
- Testing
- S-adenosyl-methionine (SAMe) capsules
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Sclerosing Cholangitis
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough The study will include patients with primary…
- Trial name
- PiSCATIN (NCT04133792)
- Testing
- Simvastatin 40mg
- Where
- 12 sites in Sweden
- Volunteers
- 571 people
- Sponsor
- Annika Bergquist
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 Cirrhosis
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients
Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high titers of serum anti-mitochondrial…
- Trial name
- NCT02477462
- Testing
- Clinic visit, Baseline visit
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Cholangitis, Sclerosing
Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis
The purpose of this research study is to determine whether the combination of UDCA and ATRA taken for 3 months will improve laboratory tests of liver and bile duct inflammation in patients with Primary Sclerosing Cholangitis…
- Trial name
- NCT01456468
- Testing
- Oral all-trans retinoic acid (ATRA)
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Yale University
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
Primary Sclerosing Cholangitis, Biliary Atresia
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism.
- Trial name
- NCT02137668
- Testing
- Oral Vancomycin
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sacramento Pediatric Gastroenterology
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
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
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
Cholestatic Pruritus
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus.
- Trial name
- NCT03995212
- Testing
- CR845 1.0 mg
- Where
- 14 sites in United States
- Volunteers
- 14 people
- Sponsor
- Cara Therapeutics, Inc.
Primary Sclerosing Cholangitis
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.
- Trial name
- ALPINE-PSC (NCT06654726)
- Testing
- aldafermin
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Liver Cirrhosis, Biliary
Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis. II.
- Trial name
- NCT00004784
- Testing
- methotrexate, ursodiol
- Volunteers
- 315 people
- Sponsor
- National Center for Research Resources (NCRR)
Cirrhosis, Cirrhosis, Liver
Liver Cirrhosis Network Cohort Study
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis.
- Conditions
- Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B
- Trial name
- LCN-C (NCT05740358)
- Where
- 14 sites in United States
- Volunteers
- 1,222 people
- Sponsor
- Northwestern University
Healthy Volunteers, Primary Sclerosing Cholangitis
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781.
- Trial name
- NCT07229911
- Testing
- TAK-781
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Takeda
Primary Sclerosing Cholangitis
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
- Trial name
- PRIMIS (NCT03890120)
- Testing
- Cilofexor
- Where
- 201 sites in United States, Australia and 14 more
- Volunteers
- 419 people
- Sponsor
- Gilead Sciences