Clinical trials: Biliary Cholestasis
Primary Biliary Cirrhosis
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.
- Trial name
- NCT03590886
- Testing
- total response Group
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Cholestasis, Genetic Liver Disorder
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Cholestatic Disorders in Patients with Genetic Liver Disorders and Healthy Individuals
Purpose The primary goal is to study liver diseases with defects in bile excretion. Investigators aim to do this using a radioactive tracer that mimics human bile and can be visualized with a PET/CT scanner.
- Trial name
- NCT06610695
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cirrhosis, Liver Inflammation
sCD163 in PBC Patients - Assessment of Treatment Response
Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC.
- Conditions
- Primary Biliary Cirrhosis, Liver Inflammation, Ursodeoxycholic Acid
- Trial name
- NCT02931513
- Testing
- Blood samples, Fibroscan, Questionnaires
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- University of Aarhus
Primary Biliary Cirrhosis
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to several symptoms such as intractable pruritus or chronic fatigue, significantly impairing patients quality of life.
- Trial name
- NCT02557360
- Testing
- S-adenosyl-L-methionine
- Where
- 2 sites in Poland
- Volunteers
- 24 people
- Sponsor
- Pomeranian Medical University Szczecin
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Trial name
- NCT03345589
- Testing
- 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic
- Where
- China
- Volunteers
- 40 people
- Sponsor
- West China Hospital
Cholestasis, Primary Sclerosing Cholangitis
Paternally Inherited Phenotypes in Cholestasis
For some years investigators have known that the health of fathers at the time their baby is conceived has an influence on the health of their child in the future.
- Conditions
- Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- PIP-C (NCT03337074)
- Testing
- Questionnaire, semen sample, fasting blood sample, Questionnaire, Questionnaire, fasting blood sample
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Liver Failure, Liver Diseases, Alcoholic
BRIDGE Device for Post-operative Pain Control
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity.
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative
- Trial name
- BRIDGE (NCT03265249)
- Testing
- BRIDGE device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Duke University
Fatigue, Primary Biliary Cirrhosis
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)
The purpose of this study is to evaluate the use of modafinil in the treatment of fatigue in patients with Primary Biliary Cirrhosis.
- Trial name
- PBC (NCT00943176)
- Testing
- Modafinil
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Mayo Clinic
Cholestasis
Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Absorption, metabolism and excretion of linerixibat have been studied in previous clinical trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion have been conducted for linerixibat.
- Trial name
- NCT03992014
- Testing
- Linerixibat tablet, [14C]-linerixibat intravenous infusion, Linerixibat oral solution
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Biliary
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver…
- Trial name
- COBALT (NCT02308111)
- Testing
- Obeticholic Acid (OCA)
- Where
- 181 sites in United States, Argentina and 29 more
- Volunteers
- 334 people
- Sponsor
- Intercept Pharmaceuticals
Cholestasis of Pregnancy
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- INTREPIDE (NCT05197387)
- Where
- 11 sites in France
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Alagille Syndrome, Cholestasis
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
- Conditions
- Alagille Syndrome, Cholestasis, Biliary Atresia
- Trial name
- NCT00007033
- Testing
- magnesium gluconate, magnesium sulfate
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Center for Research Resources (NCRR)
Cholangiocarcinoma, Pancreatic Cancer
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
- Conditions
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture
- Trial name
- RFA-Registry (NCT01439698)
- Testing
- Radio Frequency ablation Probe
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Weill Medical College of Cornell University
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Pruritus
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)
The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis.
- Trial name
- NCT05448170
- Testing
- Linerixibat
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
- Trial name
- EPICS-V (NCT07216235)
- Testing
- Saroglitazar magnesium 1 mg
- Where
- 3 sites in United States
- Volunteers
- 386 people
- Sponsor
- Zydus Therapeutics Inc.
Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC)
Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease, Primary Sclerosing Cholangitis (PSC)
- Trial name
- DISTAL (NCT07784881)
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Nantes University Hospital
Primary Biliary Cirrhosis
Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT
This is an investigator-initiated, double-blind crossover study on the mechanism of OCA treatment of patients with PBC. Hypothesis and significance The investigators will test the hypothesis that OCA administration to patients…
- Trial name
- NCT03253276
- Testing
- Obeticholic acid
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- University of Aarhus