Cholestasis

This registry will follow 20 people in China with progressive familial intrahepatic cholestasis (PFIC) who are taking odevixibat (Bylvay) as part of their normal care. The goal is to see how safe the drug is over the long term and how well it controls symptoms like severe itching…

This registry will follow 10 people with progressive familial intrahepatic cholestasis (PFIC) in South Korea who are taking odevixibat (Bylvay). The goal is to see how safe and effective the drug is over the long term in real-world use. Researchers will track side effects and how…

This study follows about 200 people who receive a special stent that naturally dissolves over time to open blocked bile or pancreatic ducts. The stent is designed to avoid the need for a second procedure to remove it. Researchers track safety and how well the stent keeps the duct…

This study tests whether adding calcitriol to vitamin D2 helps children with cholestatic liver disease correct their vitamin D deficiency faster than vitamin D2 alone. Cholestasis makes it hard for the body to absorb vitamin D. The trial will enroll 54 children and track vitamin …

This study follows 230 children with Alagille syndrome or progressive familial intrahepatic cholestasis (PFIC) who are taking Livmarli, a drug to reduce bile buildup and itching. Researchers will monitor side effects, liver function, and long-term outcomes like need for transplan…

This study tests a new stent that slowly dissolves over time to open narrowed or blocked bile ducts. About 100 people with bile duct strictures will receive the stent during a routine procedure. Researchers will track safety, how well the stent works, and whether patients feel be…

This study tests whether giving oral antibiotics after Kasai surgery can prevent cholangitis, a serious bile duct infection, in infants with biliary atresia. About 356 babies will be randomly assigned to receive either preventive antibiotics or standard care, and they will be fol…

This study tests whether a high-energy liquid formula with added vitamins can improve nutrition in children under 5 who have chronic cholestasis (a liver condition that blocks bile flow) and severe malnutrition. Fifteen children will drink the formula for 14 days, and researchers…

This study tests whether giving an antibiotic (gentamicin) directly into the bile duct during a procedure called ERCP helps people with acute cholangitis recover faster. About 172 adults with mild to moderate infection will be randomly assigned to receive either the extra antibio…

This study tests whether a high-MCT (medium-chain triglyceride) formula given before and after Kasai surgery can improve growth and nutrition in infants with biliary atresia. Biliary atresia is a rare liver condition that blocks bile flow, leading to malnutrition. The trial will …

This study looks at how safe SMOFlipid is for children and adults who need IV nutrition for 8 weeks or more. It checks if the treatment causes a lack of essential fats or liver problems. About 100 participants will be followed to see how their bodies respond.

This Phase 2 trial is testing an experimental drug called F573 in 97 people with acute liver failure or acute-on-chronic liver failure. Participants receive daily injections of F573 or a placebo for 7 days. The main goal is to check safety and side effects, while also looking at …

This study tests a new drug, LB-P8, in 87 adults with primary sclerosing cholangitis (PSC), a rare liver disease. The goal is to see if LB-P8 is safe and can lower levels of alkaline phosphatase (ALP), a marker of liver damage. Participants will receive either LB-P8 or a placebo,…

This study is testing the safety of Omegaven, a fish oil-based fat emulsion, in 40 children under 18 who have developed liver problems (cholestasis) from long-term IV nutrition. The main goal is to see how many children develop essential fatty acid deficiency during at least 8 we…

This study tests whether a fluorescent dye called indocyanine green (ICG) can help diagnose biliary atresia, a rare liver disease in infants where bile ducts are blocked. After injection, the dye is normally removed through bile and appears in stool. In infants with biliary atres…

This study tests a simple method to diagnose biliary atresia, a serious liver condition in newborns. Infants with suspected cholestasis receive a dye called indocyanine green (ICG) through an IV. Doctors then check the baby's diaper for the dye, which would indicate bile is flowi…

This study compares two types of sedation used during a procedure to drain blocked bile ducts. About 98 adults will receive either propofol-remifentanil or propofol-ketamine. The goal is to see which method leads to faster recovery, better comfort, and fewer side effects, especia…

This study tests two methods for widening a blocked bile duct during a special endoscopy procedure. One method uses a mechanical dilator, the other uses an electrocautery device. The goal is to see which causes less bleeding. The trial will involve 64 patients who cannot have sta…

This study looks for genetic changes linked to progressive familial intrahepatic cholestasis (PFIC) in adults with unexplained bile flow problems. Researchers will collect health information and blood samples from 150 participants across Spain during a single visit. The goal is t…

This study aims to collect medical data and biological samples (blood, urine, stool, and tissue) from up to 4,000 adults with known or suspected gastrointestinal diseases. Participants receive standard medical care at the NIH, and any extra samples or leftover tissue from procedu…

This study is creating a large database of information and samples from 1,000 infants with cholestasis, a condition that causes prolonged jaundice. The goal is to better understand diseases like biliary atresia and find ways to improve care. Researchers will track how the disease…

This study is collecting medical information, genetic material, and body fluid samples from over 1,200 children with biliary atresia, a rare liver disease. The goal is to find genes that cause the disease and understand how it progresses in children who still have their own liver…

This study looks at why some pregnant women develop intrahepatic cholestasis of pregnancy (ICP), a liver condition causing severe itching and higher risks for both mother and baby. Researchers will measure bile acids and check for genetic changes in 150 Indian women with and with…

This study looks at how common tooth staining is in children who had very high bilirubin levels (jaundice) early in life. Researchers will check 120 children with certain liver conditions to see if their teeth are discolored and whether that affects their daily life. The goal is …

This study creates a Canadian registry for children under 18 with Alagille syndrome or genetic intrahepatic cholestasis, rare liver conditions that cause bile buildup. Researchers will collect health data from medical records over time to understand how these diseases progress an…

This registry will follow 510 adults undergoing therapeutic endoscopic ultrasound (EUS) for conditions like stomach or bile duct blockages, pancreatic fluid collections, or gallbladder inflammation. The goal is to see how well these procedures work over the long term and what fac…

This study looks at how a special high-MCT (medium-chain triglyceride) diet affects growth in infants with biliary atresia after Kasai surgery. Researchers will track weight and length in 300 babies under 3 months old. The goal is to gather information, not to test a new treatmen…

This study is using advanced whole-genome sequencing to find hidden genetic causes of cholestatic liver disease in adults whose condition remains unexplained after standard tests. Researchers will compare the DNA of 60 affected adults to a large group of healthy controls. The goa…

This study is looking at whether a substance called FGF19 in the blood, measured before surgery, can help predict how well children with biliary atresia will do after their operation. Researchers will follow 200 children for one year after surgery, checking liver function and whe…

This observational study is looking at pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that raises bile acids and can harm the baby. Researchers want to see if measuring specific bile acid types in the mother's and baby's blood can help predict …

This study is monitoring 50 children in Japan with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC) who are taking the drug Livmarli (maralixibat). Researchers are using a national registry to track how many children develop liver problems and how …

This study compares two advanced techniques used when doctors have trouble reaching the bile duct during a procedure called ERCP. About 188 adults with difficult bile duct access will be randomly assigned to either an endoscopic ultrasound-guided rendezvous technique or an early …

This study tracks 1,000 patients undergoing major liver, pancreas, or bile duct surgery to see if the time it takes for their albumin levels to return to normal can predict complications and length of hospital stay. Albumin is a protein that drops after surgery due to inflammatio…

This study aims to collect medical history, family history, and blood or urine samples from 10,000 people with or at risk for pancreatic cancer. Researchers will use this information to look for genetic and environmental factors linked to the disease. Participants may also be ask…

This early-stage study will test a drug called saroglitazar magnesium in 6 adults with moderate liver scarring (cirrhosis) caused by cholestatic liver disease. The main goal is to see how the drug moves through the body and if it is safe when taken every other day. Participants w…

This study aims to uncover the genetic and developmental causes of biliary atresia, a rare condition that leads to liver failure in newborns and accounts for half of all childhood liver transplants worldwide. Researchers will analyze DNA from 1,100 children who have had or need a…