Clinical trials: Cholestasis
Cholestatic Liver Disease, Chronic Liver Disease (CLD)
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease.
- Conditions
- Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency, Children
- Trial name
- VITD-CHOL (NCT07670611)
- Testing
- Vitamin D2, Calcitriol
- Where
- Thailand
- Volunteers
- 54 people
- Sponsor
- Chulalongkorn University
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
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
Primary Biliary Cirrhosis
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
The study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (PBC).
- Trial name
- MSCsTreatPBC (NCT01440309)
- Testing
- Biological: mesenchymal stem cell, ursodeoxycholic acid
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Robert Chunhua Zhao, MD, PhD
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by…
- Trial name
- NCT00826020
- Testing
- Omegaven™
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Nebraska
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
- Conditions
- Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct, Biliary Stricture
- Trial name
- NCT03821025
- Testing
- Biliary stent
- Where
- South Africa
- Volunteers
- 150 people
- Sponsor
- University of Cape Town
Bile Duct Obstruction
A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered.
- Trial name
- NCT03628001
- Testing
- ERCP
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Clinico Humanitas
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
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.
Autoimmune Liver Disease, Autoimmune Hepatitis
TruGraf Liver Gene Expression Serial Test
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months…
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT06061341
- Testing
- TruGraf®
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Washington University School of Medicine
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
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
Intrahepatic Cholestasis of Pregnancy
Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy
This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP.
- Trial name
- NCT06366659
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Peking University
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives.
- Trial name
- NCT07185919
- Where
- 5 sites in South Korea
- Volunteers
- 10 people
- Sponsor
- Ipsen
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Strictures Caused by Malignant Neoplasms
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary…
- Trial name
- NCT00713427
- Testing
- WallFlex™ Biliary Partially-Covered Stent
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Gallstone Disease
Radiological Investigation of Bile Duct Obstruction
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed.
- Trial name
- RIBO (NCT02351492)
- Testing
- Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography, magnet resonance imaging
- Where
- Switzerland
- Volunteers
- 122 people
- Sponsor
- University Hospital, Basel, Switzerland
Liver Fibrosis, Liver Cirrhosis
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity
Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases.
- Conditions
- Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour
- Trial name
- NARFI (NCT01082419)
- Testing
- ARFI measurement
- Where
- France
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux