Clinical trials: Cholestasis of Pregnancy
Intrahepatic Cholestasis of Pregnancy
The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.
- Trial name
- NCT01965054
- Testing
- Fish Oil Supplement Group
- Sponsor
- Icahn School of Medicine at Mount Sinai
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Intrahepatic Cholestasis of Pregnancy
Maralixibat for Intrahepatic Cholestasis of Pregnancy
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
- Trial name
- METAPHOR (NCT07389031)
- Testing
- Maralixibat
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Intrahepatic Cholestasis of Pregnancy
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
- Trial name
- NCT07560722
- Testing
- Normal Saline (0.9% NaCl), Esketamine 0.3mg/kg
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Tianjin Medical University General Hospital
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Intrahepatic Cholestasis
Induction of Labor in Intrahepatic Cholestasis of Pregnancy
Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications.
- Trial name
- ILICP (NCT01381939)
- Volunteers
- 5,000 people
- Sponsor
- Karolinska Institutet
Primary Biliary Cholangitis, Heart Failure
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time.
- Conditions
- Primary Biliary Cholangitis, Heart Failure, Digestive Diseases, Women Who Have Experienced a Cardiac Event
- Trial name
- EMPOwer (NCT05786482)
- Testing
- Online mind-body wellness program, Online mind-body wellness program + Weekly Check-ins
- Where
- Canada
- Volunteers
- 825 people
- Sponsor
- University of Alberta
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
Intrahepatic Cholestasis of Pregnancy, Gestational Diabetes Mellitus
The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus
ICP is known to cause abnormal bile acid homeostasis and to be associated with an increased risk of diseases of the biliary system in later life. There have been small studies (Dann et al. 2006; Wójcicka-Jagodzińska et al.
- Trial name
- NCT01499524
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Imperial College London
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
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
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
Intrahepatic Cholestasis, Pregnancy
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT01576458
- Testing
- ursodeoxycholic acid
- Where
- Finland
- Volunteers
- 20 people
- Sponsor
- Turku University Hospital
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 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
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
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
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum 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