Clinical trials: Biliary Stasis
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Cholestasis, Primary Sclerosing Cholangitis
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.
- Conditions
- Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT01879735
- Testing
- 11C-CSar, ICG
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Alagille Syndrome
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
- Trial name
- NCT07585097
- Where
- 14 sites in France, Italy
- Volunteers
- 30 people
- Sponsor
- Ipsen
PBC, Primary Biliary Cirrhosis
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with…
- Trial name
- CLARITY (NCT01904058)
- Testing
- LUM001, Ursodeoxycholic Acid
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.
- Trial name
- NCT06309589
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Yilihamu·Abilitifu
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
Primary Biliary Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Cirrhosis, Primary
IBAT Inhibitor A4250 for Cholestatic Pruritus
This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250
- Trial name
- NCT02360852
- Testing
- A4250
- Where
- Sweden
- Volunteers
- 9 people
- Sponsor
- Sahlgrenska University Hospital
Primary Biliary Cholangitis
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of…
- Trial name
- NCT04620733
- Testing
- Seladelpar 10 mg, Seladelpar 5 mg
- Where
- 134 sites in United States, Argentina and 24 more
- Volunteers
- 193 people
- Sponsor
- Gilead Sciences
Cholestasis, Short Bowel Syndrome
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).
- Trial name
- Omegaven (NCT01297933)
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
Cholestasis, Intrahepatic Cholestasis of Pregnancy
Investigation of the Pruritogens of Liver-related Diseases
This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT06364969
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Peking University
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
The purpose of this study is to create a national, multi-centre registry for children with Alagille syndrome (ALGS) and Genetic Intrahepatic Cholestasis (GIC) that follows participants long-term, ensuring standardized…
- Conditions
- PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), Cholestasis, Intrahepatic
- Trial name
- PEARL (NCT07411716)
- Where
- 13 sites in Canada
- Volunteers
- 220 people
- Sponsor
- Children's Hospital of Eastern Ontario
Cholestasis, Parenteral Nutrition
Cholestasis Prevention: Efficacy of IV Fish Oil
Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury…
- Trial name
- NCT00512629
- Testing
- Omegaven, Intralipid
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston Children's Hospital
Alagille Syndrome, Pulmonary Artery Stenoses
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
The goal of this interventional study is to test a hemostasis screening protocol and cardiac peri-procedural and post-operative hemostasis pathway to improving bleeding complications and improve patient survival for children with…
- Conditions
- Alagille Syndrome, Pulmonary Artery Stenoses, Acquired Von Willebrand Disease
- Trial name
- NCT05846854
- Testing
- Assessment for bleeding disorder with tailored post-operative care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
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
Primary Sclerosing Cholangitis
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible…
- Trial name
- VISTAS (NCT04663308)
- Testing
- Volixibat
- Where
- 103 sites in United States, Argentina and 12 more
- Volunteers
- 182 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Ursodeoxycholic Acid, Primary Biliary Cirrhosis
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost…
- Trial name
- NCT03489889
- Testing
- Ursodeoxycholic Acid 300mg tablet, Ursodeoxycholic Acid 300mg capsule
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Biliary Cholangitis (PBC)
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment.
- Trial name
- NCT06591468
- Testing
- Prednisone, UDCA (Ursodeoxycholic acid)
- Where
- 2 sites in China
- Volunteers
- 244 people
- Sponsor
- Han Ying