Clinical trials: Biliary Cholestasis
Primary Biliary Cirrhosis
Online Wellness Intervention for Primary Biliary Cholangitis (PBC)
Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic…
- Trial name
- NCT04791527
- Testing
- Mind-body therapy
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of Alberta
Liver Cirrhosis, Biliary
SAMe to Treat Biliary Cirrhosis Symptoms
This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver.
- Trial name
- NCT00125281
- Testing
- S-adenosyl-methionine (SAMe) capsules
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatobiliary Disease, Biliary Atresia
Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis.
- Conditions
- Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT03898765
- Testing
- Dry blood spot screening
- Where
- China
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Intrahepatic Cholestases, Pregnancy Complications
Metformin in Intrahepatic Cholestasis of Pregnancy
This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.
- Trial name
- METRIC (NCT03056274)
- Testing
- Metformin, Ursodeoxycholic Acid
- Volunteers
- 40 people
- Sponsor
- Epsom and St Helier University Hospitals NHS Trust
Primary Biliary Cholangitis (PBC)
Fenofibrate in Primary Biliary Cholangitis: a Real World Study
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT06755151
- Testing
- Fenofibrate
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cholangitis (PBC)
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC).
- Trial name
- NCT07631442
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
Intrahepatic, Cholestasis
Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions
Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN).
- Trial name
- NCT02633384
- Testing
- SMOFlipid, Lipofundin
- Volunteers
- 52 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
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 Cirrhosis (PBC)
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT02609048
- Testing
- Experimental: Seladelpar 50 mg, Experimental: Seladelpar / MBX-8025 200 mg
- Where
- 49 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Cholestasis
Compassionate Use of Omegaven
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously.
- Trial name
- NCT02778698
- Testing
- Omegaven
- Sponsor
- Geisinger Clinic
Primary Biliary Cirrhosis
Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis
This disease is believed to be due to immune cells, cells which normally protect the body, but are now destroying the bile ducts in the liver. When the ducts are damaged, bile builds up in the liver and damages liver tissue.
- Trial name
- NCT00393185
- Testing
- Non-myeloablative Hematopoietic Stem Cell Transplantation
- Sponsor
- Richard Burt, MD
Cholestasis, Icterus
FGF19 in Obstructive Cholestasis: "Unveil the Signal"
Rationale: Bile salts are potent signalling molecules influencing various metabolic and functional processes. Bile salts exert these functions by activating nuclear (e.g. FXR ) and plasma cell membrane-bound receptors (e.g.
- Conditions
- Cholestasis, Icterus, Cholangiocarcinoma, Pancreatic Neoplasms
- Trial name
- FOCUS (NCT05718349)
- Testing
- Biospecimen sampling
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Nicole Hildebrand
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Biliary, Biliary Cirrhosis, Primary
Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC)
Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women. It causes slowly progressive liver disease, which eventually causes liver failure, requiring a liver transplant.
- Trial name
- NCT00145964
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- University Health Network, Toronto
Primary Biliary Cirrhosis
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high…
- Trial name
- NCT03226067
- Testing
- GKT137831
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Calliditas Therapeutics AB
Liver Transplantation, Hepatitis
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
- Conditions
- Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
- Trial name
- NCT00080236
- Testing
- IDN-6556
- Where
- 13 sites in United States, Germany
- Volunteers
- 99 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Primary Biliary Cholangitis (PBC)
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.
- Trial name
- NCT07906639
- Testing
- Elafibranor
- Volunteers
- 50 people
- Sponsor
- Ipsen