Clinical trials: Biliary Cholestasis
Liver Cirrhosis, Biliary
Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk.
- Trial name
- CBP-HOPE (NCT03630718)
- Testing
- Psychoeducational Intervention, Hypnosis intervention
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Primary Biliary Cirrhosis
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02026401
- Testing
- NGM282
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Liver Diseases, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Multiparametric MRI
This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS…
- Conditions
- Liver Diseases, Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- Trial name
- NCT03743272
- Testing
- LiverMultiScan
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Perspectum
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
Primary Biliary Cholangitis
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
- Trial name
- NCT06888115
- Testing
- CS0159
- Where
- 3 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Intrahepatic Cholestasis of Pregnancy
Ursodeoxycholic Acid And Cholestasis Of Pregnancy
The study is a multicenter randomized double blind placebo controlled trial. The study will be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy (ICP) in third level hospitals (that are also…
- Trial name
- CERTO (NCT01226823)
- Testing
- Ursodeoxycholic Acid
- Where
- 7 sites in Italy
- Sponsor
- University of Bologna
Primary Biliary Cholangitis
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices…
- Trial name
- NCT05624294
- Testing
- CS0159
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
Cholangitis
Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Background and aims: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an…
- Trial name
- NCT02098486
- Testing
- Moxifloxacin, ceftriaxone
- Where
- South Korea
- Volunteers
- 86 people
- Sponsor
- Kangbuk Samsung Hospital
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states.
- Trial name
- NCT02200029
- Testing
- Ademetionine IV+tablet, Ademetionine tablet
- Where
- 12 sites in Russia
- Volunteers
- 75 people
- Sponsor
- Abbott
Primary Biliary Cirrhosis
Use of Fenofibrate for Primary Biliary Cirrhosis
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
- Trial name
- NCT00575042
- Testing
- Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Autoimmune Hepatitis, Primary Sclerosing Cholangitis
Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.
- Conditions
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Non-Alcoholic Fatty Liver Disease, Liver Abscess
- Trial name
- LGAS (NCT06519162)
- Where
- South Korea
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Chungnam National University Hospital
Progressive Familial Intrahepatic Cholestasis
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion
The natural course of PFIC syndromes and the effect of diversion techniques, have so far not been characterized in a rigorous manner within a larger population of patients.
- Trial name
- NAPPED (NCT03930810)
- Testing
- Surgical biliary diversion
- Where
- Netherlands
- Volunteers
- 1,500 people
- Sponsor
- University Medical Center Groningen
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.