Clinical trials: Intrahepatic Cholestasis of Pregnancy
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, 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
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
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
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
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of…
- Trial name
- NCT01898832
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education 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
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
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
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
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
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
Intrahepatic Cholestasis of Pregnancy
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the…
- Trial name
- BAPP (NCT07428226)
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Jena University Hospital
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
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
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
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
Chronic Pancreatitis, Inflammatory Bowel Diseases
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect…
- Conditions
- Chronic Pancreatitis, Inflammatory Bowel Diseases, Hepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- GREAT1 (NCT04306939)
- Testing
- venipuncture, Questionnaires, Additional Sample Collections
- Where
- United States
- Volunteers
- 120,000 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
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
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