Clinical trials: Cholestasis, Intrahepatic
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
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
Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Biobank for Cholestatic Liver Diseases.
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis…
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer
- Trial name
- NCT03445585
- Where
- United States
- Volunteers
- 9,150 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Chronic Liver Disease
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death.
- Trial name
- FALL (NCT05335603)
- Where
- Denmark
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Cholestasis, Intrahepatic Cholestasis of Pregnancy
Investigation of the Pruritogens of Liver-related Diseases
This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT06364969
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Peking University
Cholestasis of Pregnancy
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- INTREPIDE (NCT05197387)
- Where
- 11 sites in France
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Intrahepatic Cholestasis of Pregnancy
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.
- Trial name
- NCT05637151
- Testing
- clamp time of umbilical
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics.
- Trial name
- NCT04640571
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Liver Cirrhosis, Biliary
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia
- Trial name
- NCT03468699
- Testing
- Autologous BMMC transplantation
- Where
- 2 sites in Vietnam
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
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
Intrahepatic Cholestasis of Pregnancy, Genetic Mutation
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol/L (and elevated serum transaminases), with increased risks of perinatal complications, including…
- Conditions
- Intrahepatic Cholestasis of Pregnancy, Genetic Mutation, Health Related Quality of Life
- Trial name
- ICP (NCT05691036)
- Where
- India
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Cholestatic Liver Disease, Progressive Familial Intrahepatic Cholestasis
DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE
Cholestatic disease in adults comprises a heterogeneous group of conditions characterized by intra- or extrahepatic alterations of bile flow that can lead to fibrosis or hepatic decompensation.
- Trial name
- FIRST (NCT07317193)
- Testing
- Advanced Whole Genome Sequencing to Identify Rare Pathogenic Variants in Unexplained Cholestatic Liver Disease
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Intrahepatic Cholestasis of Pregnancy
Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy
This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP.
- Trial name
- NCT06366659
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Peking University
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
Study of [14C]CS0159 in China Healthy Subjects
Study of [14C]CS0159 in China Healthy Subjects.
- Trial name
- NCT06098027
- Testing
- [14C]CS0159
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Quantitative MRCP
This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP).
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Gallstones, Liver Diseases
- Trial name
- NCT03809559
- Testing
- MRCP+
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Perspectum
Intrahepatic Cholestasis of Pregnancy
The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP)
This is an exploratory non-therapeutic study to study the microbiome patterns during pregnancy in women with ICP in order to identify specific bacterial strains for further product development.
- Trial name
- NCT05151913
- Testing
- Exploratory
- Where
- 2 sites in Sweden
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- MetaboGen AB
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
Cholestasis of Pregnancy, Intrahepatic Cholestasis of Pregnancy
Bile Acid Effects in Fetal Arrhythmia Study
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder of pregnancy that typically presents in late pregnancy with generalised itching.
- Conditions
- Cholestasis of Pregnancy, Intrahepatic Cholestasis of Pregnancy, Obstetric Cholestasis
- Trial name
- BEATS (NCT03519399)
- Testing
- Monica AN24
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust