View clinical trials related to Cholestasis, Intrahepatic.
Filter by: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. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.
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.
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus associated with PFIC.
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%. Women diagnosed with ICP most often present with itching, which may be severe. More concerning, however, is the impact of ICP on adverse fetal and pregnancy outcomes, including preterm delivery, meconium exposure, fetal demise, and increased neonatal respiratory complications. The risk for fetal demise has been estimated to be 1-3%. The mechanism of fetal demise in ICP is unknown, and therefore cannot be reliably predicted. There is evidence to suggest that extremely elevated bile acids levels are associated with worse fetal outcomes, particularly levels greater than 40 μmol/L. Ursodeoxycholic acid (UDCA) has anticholestatic effects, and is used to treat a variety of cholestatic liver diseases. Many studies have demonstrated superiority of UDCA over other agents, including dexamethasone and cholestyramine, for relief of maternal pruritus, improvement in transaminitis, reduction in serum bile acid concentrations, and improved pregnancy outcomes. As a result, UDCA is now widely used as first-line treatment for symptomatic relief in patients with ICP. Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are two omega-3 long chain polyunsaturated fatty acids found in fish. DHA is known to play a key role in early fetal brain development, and has been associated with modest beneficial effects on neurodevelopmental and cognitive outcomes in children. In neonates with parental nutrition-induced cholestasis (PN-cholestasis), parental fish oil has been shown to be hepatoprotective not only for treatment of PN-cholestasis, but for prevention of cholestasis in premature infants at risk for the disease. Our hypothesis is that fish oil supplementation with DHA in women with ICP who are treated with UDCA will increase the rate of decline in serum total bile acid levels. The incidence of ICP at a single hospital center in Queens, NY is estimated to be 5% secondary to a high concentration of patients from high-risk ethnic groups. High risk patients with bile acid levels greater than or equal to 40 μmol/L are managed aggressively with inpatient admission for continuous fetal monitoring, treatment with UDCA, and serial total bile acid levels weekly. These are patients are routinely offered early delivery after documented fetal lung maturity between 36 and 37 weeks gestation, or for any signs of fetal distress. This study is a prospective randomized controlled trial comparing weekly serum total bile acid levels in women admitted for inpatient management of ICP among women supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin and DHA.
This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
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. It is a double-blind, crossover study with subjects receiving placebo or GSK23306772 in random order during two 14-day treatment periods. Additionally, the study will determine GSK2330672 exposure and interactions with ursodeoxycholic acid (UDCA). The total duration of subject participation will be 14 weeks for screening (45 days) and the treatment period. Subjects who are eligible for enrolment will participate in a 2-week placebo run-in period. Subjects will be randomized in a crossover fashion (Sequence 1 / Sequence 2) to receive placebo or GSK2330672 treatment during two consecutive 2-week study periods. Subjects will then participate in a 2-week placebo dosing follow-up period ending in final follow-up assessments. Study results will be utilized to form a benefit: risk profile for GSK2330672 in PBC that will determine plans for progression to exploratory efficacy trials
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 pregnancy.
This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.