Clinical trials: Biliary Stasis
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
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
Biliary Atresia, Intrahepatic Cholestases
Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)
A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted.
- Conditions
- Biliary Atresia, Intrahepatic Cholestases, Normal Controls
- Trial name
- BA (NCT03890536)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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
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
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
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
Neonatal Cholestasis, Total Parenteral Nutrition Effect
Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)
The aim of this study is to evaluate the risk factors of PNAC in neonates
- Trial name
- TPN (NCT05163145)
- Testing
- TPN
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mayyada Elsayed Mohamed Hussien
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
Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes
Diet in Twin Pregnancy: the Wellness of Mother and Babies.
The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular: incidence of maternal obstetric complications: gestational diabetes gestational hypertension or preeclampsia…
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy
- Trial name
- FIT (NCT05773677)
- Testing
- Specific Diet
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Icterus
Expression of BCRP in Icteric Patients
The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP)…
- Trial name
- NCT00295360
- Testing
- no intervention, pathophysiological study
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Pregnancy
Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.
Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially late second and third trimester. We aimed to investigate the role of apoptosis in etiopathogenesis of obstetric cholestasis.
- Trial name
- NCT02192177
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Liver Fibrosis, Liver Cirrhosis
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity
Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases.
- Conditions
- Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour
- Trial name
- NARFI (NCT01082419)
- Testing
- ARFI measurement
- Where
- France
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Cholestasis in Newborn, Biliary Atresia
The Dirty Nappy Study
This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns.
- Conditions
- Cholestasis in Newborn, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT07697872
- Where
- United Kingdom
- Volunteers
- 5,350 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's and Children's NHS Foundation Trust
Cholestasis, Red Cell Membrane and Enzyme Abnormalities
Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease
Objective: The investigators propose to perform ektacytometry on 20 pediatric patients over age one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl.
- Trial name
- NCT05582447
- Testing
- ektacytometry of red blood cells
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
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
Biliary Atresia, Neonatal Cholestasis
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major…
- Conditions
- Biliary Atresia, Neonatal Cholestasis, Infantile Hepatitis Syndrome
- Trial name
- NCT03842150
- Testing
- biliary atresia screen score
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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