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Cholestasis, Intrahepatic clinical trials

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NCT ID: NCT06183242 Recruiting - Clinical trials for Cholestasis, Intrahepatic

Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis

Start date: May 27, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention, occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis.

NCT ID: NCT05773677 Recruiting - Clinical trials for Gestational Diabetes

Diet in Twin Pregnancy: the Wellness of Mother and Babies.

FIT
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

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 - intrahepatic cholestasis (ICP) - fetal growth, development and birth weight of the babies

NCT ID: NCT05704517 Recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Progressive Familial Intrahepatic Cholestasis in Indian Children - Establishing an Indian PFIC Registry

Start date: January 28, 2023
Phase:
Study type: Observational

The project will amalgamate data from several large Indian centers to describe the genotype, clinical spectrum, natural course, genotype-phenotype correlation, outcome, and response to medical therapy in Indian children with progressive familial intrahepatic cholestasis (PFIC). This will be the first such Indian registry of children with PFIC. There are currently limited single-center studies describing the genotype, natural course, and outcome of Indian children with PFIC. Data will be collected retrospectively from the participating centers across the country. Only genetically confirmed cases would be included.

NCT ID: NCT05691036 Recruiting - Clinical trials for Health Related Quality of Life

Bile Acids Metabolism and Genetic Mutation Profile in the ICP in the Indian Population

ICP
Start date: December 8, 2022
Phase:
Study type: Observational

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 spontaneous preterm labor, fetal distress, infant respiratory distress syndrome, meconium-stained liquor (MSL), and sudden intrauterine death (IUD). The Incidence of ICP varies from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).

NCT ID: NCT05687474 Recruiting - Cystic Fibrosis Clinical Trials

Baby Detect : Genomic Newborn Screening

Start date: September 1, 2022
Phase:
Study type: Observational

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

NCT ID: NCT05637151 Recruiting - Clinical trials for 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

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

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. Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group (ICC in pregnant women with ICP)and 50 cases of delayed cord clamping group(DCC in pregnant women with ICP), and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group (ICC in normal pregnant women)and 50 cases of delayed cord clamping group(DCC in normal pregnant women). The bilirubin levels of neonates in each group were compared.

NCT ID: NCT05197387 Recruiting - Clinical trials for Cholestasis of Pregnancy

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

INTREPIDE
Start date: June 21, 2022
Phase:
Study type: Observational

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). If so, it would suggest the potential benefit of immunomodulatory therapeutics.

NCT ID: NCT04281082 Recruiting - Clinical trials for Cholestasis of Pregnancy

Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives

Start date: January 1, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT04071197 Recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus. Their treatment poses a great challenge, with medical treatment is not successful in many cases. Moreover, the available non-transplant surgeries carry many side effects and different degrees of efficacy. Partial external biliary diversion, internal biliary diversion, and ileal exclusion still lack widespread experience with many side effects. Nasobiliary stent placement has little tolerability, especially in younger age. Gastrobiliary tube is a novel modality for external biliary diversion in such patients.

NCT ID: NCT03834285 Recruiting - Cirrhosis, Liver Clinical Trials

Liver Disease in Pregnancy

Start date: May 9, 2019
Phase:
Study type: Observational

Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts. Moreover, the population prevalence of these diseases is low and to-date, it has proven difficult to generate reliable data at a patient level. This is a multi-center, prospective cohort study that will open at 3 centers within the UK; and 4 centers in the European Union. The investigators will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy. The main rationale behind this study is to establish a platform that enables detailed review of the outcomes of these rare diseases; to help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.