Clinical trials: Biliary Stasis
Alagille Syndrome
Positional Cloning of the Gene(s) Responsible for Alagille Syndrome
The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach.
- Trial name
- NCT00001642
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Byler Disease
Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease
Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The disease is typically manifest in the first year of life on the basis of complications of cholestasis; common presentations include…
- Trial name
- NCT02094222
- Testing
- RAVICTI
- Sponsor
- Robert Squires, Jr.
Cholestasis
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the…
- Trial name
- NCT00004410
- Testing
- tauroursodeoxycholic acid
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Primary Biliary Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC.
- Trial name
- ELONSEN (NCT06730061)
- Testing
- Elafibranor
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Ipsen
Bile Duct Obstruction
Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain…
- Trial name
- FLUSH (NCT04915703)
- Testing
- Flushing of PTBD catheter
- Where
- Netherlands
- Volunteers
- 38 people
- Sponsor
- Erasmus Medical Center
Bile Duct Obstruction, Extrahepatic
Reconstruction of the Bile Duct With the Round Ligament
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament
- Trial name
- NCT03030573
- Testing
- Reconstruction of the bile duct with the round ligament
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Beaujon 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, Growth Failure
SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury
While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day.
- Trial name
- SMOF (NCT02412566)
- Testing
- SMOFlipid
- Where
- United States
- Sponsor
- Baylor College of Medicine
Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy
Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
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.
- Conditions
- Diabetes Mellitus, Intrahepatic Cholestasis of Pregnancy, Metabolic Disease
- Trial name
- MRI-TIME (NCT04890886)
- Testing
- Thermal imaging, Echocardiogram, ECG
- Volunteers
- 80 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Cholestasis
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
- Trial name
- NCT01194063
- Testing
- Omega-3 fish oil lipid emulsion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Kapiolani Medical Center For Women & Children
Hepatitis, Alcoholic
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
- Trial name
- NCT02024295
- Testing
- Ademethionine, Polyene Phosphatidyl choline
- Where
- 2 sites in China
- Volunteers
- 118 people
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Cholestasis, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
Intrahepatic Cholestasis of Pregnancy
Maralixibat for Intrahepatic Cholestasis of Pregnancy
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
- Trial name
- METAPHOR (NCT07389031)
- Testing
- Maralixibat
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Primary Sclerosing Cholangitis, Cholestasis
Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy
The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic…
- Trial name
- BEZASCLER (NCT04309773)
- Testing
- Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy
- Where
- France
- Volunteers
- 104 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cholestatic Liver Disease
Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.The more hydrophillic bile acid…
- Trial name
- NCT01829698
- Testing
- tauroursodeoxycholic, ursodeoxycholic acid
- Where
- China
- Volunteers
- 199 people
- Sponsor
- Beijing Trendful Kangjian Medical Information Consulting Limited Company
Primary Biliary Cholangitis
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients.
- Trial name
- NCT05751967
- Testing
- Fenofibrate Combined With Ursodeoxycholic Acid
- Where
- 7 sites in China
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02135536
- Testing
- NGM282
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 36 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences