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Cholestasis, Intrahepatic clinical trials

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NCT ID: NCT06366659 Not yet recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP.

NCT ID: NCT06364969 Not yet recruiting - Cholestasis Clinical Trials

Investigation of the Pruritogens of Liver-related Diseases

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch.

NCT ID: NCT04890886 Not yet recruiting - Diabetes Mellitus Clinical Trials

Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases

MRI-TIME
Start date: June 1, 2021
Phase:
Study type: Observational

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. This observational feasibility study aims to investigate the effect of maternal MD on fat distribution, lipid content and metabolic phenotype of different neonatal tissues. We will explore whether differences in tissue fat distribution and lipid content are observed in the neonates of women with MD during pregnancy, compared to those who have a healthy, uncomplicated pregnancy and if there are changes in how the different tissues work (e.g. cardiac function). If there is evidence to show that there are alterations during pregnancy in children of women with MD, this will help inform potential interventions to ensure optimal child health.

NCT ID: NCT03890536 Not yet recruiting - Biliary Atresia Clinical Trials

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

BA
Start date: December 2023
Phase:
Study type: Observational

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. The hypothesis of the study is "infants with biliary atresia have a unique microbiome signature at the time of diagnosis and changes in population dynamics occur during disease progression". The microbiome will be determined at diagnosis and at well-defined time points during the natural history of the disease.

NCT ID: NCT03056274 Not yet recruiting - Clinical trials for Pregnancy Complications

Metformin in Intrahepatic Cholestasis of Pregnancy

METRIC
Start date: January 2019
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT01226823 Not yet recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Ursodeoxycholic Acid And Cholestasis Of Pregnancy

CERTO
Start date: November 2010
Phase: Phase 3
Study type: Interventional

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 Academic Hospitals). Pregnant women at the time of ICP diagnosis will be randomized in two groups: Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery. The hypotheses are that UDCA treatment will be superior to placebo and effective in: reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.