Clinical trials: Intrahepatic Cholestasis
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
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
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
Hereditary Diseases, Cholestasis, Intrahepatic
BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases
The purpose of the study is to improve the prognosis of inhereditary cholestasis caused by ABCB11 gene mutations by using BSEP function rescue drugs
- Trial name
- NCT04531878
- Testing
- 4-Phenylbutyrate
- Sponsor
- Children's Hospital of Fudan University
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
Cholestasis of Pregnancy
Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives
To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.
- Trial name
- NCT04281082
- Testing
- ursofalk
- Where
- Greece
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Alexandra Hospital, Athens, Greece
Intrahepatic Cholestasis of Pregnancy
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of…
- Trial name
- NCT04922580
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy
Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
There is limited knowledge about the extent of the impact of maternal metabolic diseases (MD) and/or alterations in maternal serum lipid content upon neonatal lipid distribution and phenotypes.
- Conditions
- Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy, Metabolic Disease
- Trial name
- MRI-TIME (NCT04890886)
- Testing
- Thermal imaging, Echocardiogram, ECG
- Volunteers
- 80 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Progressive Familial Intrahepatic Cholestasis
Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders
Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus.
- Trial name
- NCT04071197
- Testing
- Gastostomy-biliary tube, External biliary diversion, internal biliary diversion and nasobiliary tube
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- National Liver Institute, Egypt
Pregnancy Disease, Cirrhosis, Liver
Liver Disease in Pregnancy
Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts.
- Conditions
- Pregnancy Disease, Cirrhosis, Liver, HELLP Syndrome, AFLP - Acute Fatty Liver of Pregnancy
- Trial name
- NCT03834285
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- King's College Hospital NHS Trust
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
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.
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT03353454
- Testing
- Maralixibat
- Sponsor
- Mirum Pharmaceuticals, Inc.
Byler Disease
Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease
Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The disease is typically manifest in the first year of life on the basis of complications of cholestasis; common presentations include…
- Trial name
- NCT02094222
- Testing
- RAVICTI
- Sponsor
- Robert Squires, Jr.
Intrahepatic Cholestases, Pregnancy Complications
Metformin in Intrahepatic Cholestasis of Pregnancy
This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.
- Trial name
- METRIC (NCT03056274)
- Testing
- Metformin, Ursodeoxycholic Acid
- Volunteers
- 40 people
- Sponsor
- Epsom and St Helier University Hospitals NHS Trust
Cholestasis, Intrahepatic
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
This will be a randomized, double-blind, placebo-controlled study to assess safety and tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC) and symptoms of pruritus.
- Trial name
- NCT01899703
- Testing
- GSK2330672, Ursodeoxycholic acid
- Where
- 3 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Intrahepatic, Cholestasis
Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions
Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN).
- Trial name
- NCT02633384
- Testing
- SMOFlipid, Lipofundin
- Volunteers
- 52 people
- Sponsor
- Centro Hospitalar de Lisboa Central
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
Intrahepatic Cholestasis of Pregnancy
Serum Autotaxin Levels in Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy.
- Trial name
- NCT02480478
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Cholestasis in Newborn
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN.
- Trial name
- NCT02692326
- Testing
- Cyclic parenteral nutrition
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Hospital General Universitario Gregorio Marañon