Clinical trials: Primary Biliary Cholangitis (PBC)
PBC
Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that eventually leads to end-stage liver failure and death unless liver transplantation (LT) is performed.
- Trial name
- BEZURSO (NCT01654731)
- Testing
- Bezafibrate
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Liver Cirrhosis, Biliary
Ursodiol-Methotrexate for Primary Biliary Cirrhosis
The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective than treatment with UDCA alone.
- Trial name
- NCT00006168
- Testing
- Methotrexate
- Where
- 12 sites in United States
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PBC, Primary Biliary Cholangitis (PBC)
Epidemiology of PrImary Biliary Cholangitis in Spain
Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant.
- Trial name
- EPIC-PBC (NCT07821463)
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Fundacio Privada Mon Clinic Barcelona
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
- Trial name
- PBC-Phase 2 (NCT02943447)
- Testing
- Cilofexor
- Where
- 25 sites in United States, Austria and 2 more
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
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
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 Cholangitis (PBC)
RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary…
- Trial name
- RELIEF (NCT07161245)
- Testing
- Multimodal prehabilitation, standard of care
- Where
- Spain
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona
Primary Biliary Cholangitis
Study of [14C]CS0159 in China Healthy Subjects
Study of [14C]CS0159 in China Healthy Subjects.
- Trial name
- NCT06098027
- Testing
- [14C]CS0159
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Short Bowel Syndrome, Intestinal Resection
Gastrointestinal Hormone Secretion, Intestinal Permeability and Short Bowel Syndrome
The gastrointestinal tract is a complex endocrine organ that regulates a wide range of physiological processes, including those involved in the digestion of nutrients.
- Trial name
- NCT07235670
- Testing
- Standardized meal
- Where
- Denmark
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Liver Cirrhosis, Biliary
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
- Trial name
- NCT00406237
- Testing
- tigecycline
- Where
- 3 sites in United States, Puerto Rico
- Volunteers
- 8 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Primary Bilary Cirrhosis (PBC)
Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.
- Trial name
- SENSE registry (NCT07549607)
- Where
- 21 sites in Germany, Switzerland
- Volunteers
- 100 people
- Sponsor
- University of Leipzig
Primary Biliary Cholangitis (PBC)
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT07104201
- Testing
- Fenofibrate
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cholangitis, Liver Fibrosis
Patients With Primary Biliary Cholangitis(PBC)
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced…
- Conditions
- Primary Biliary Cholangitis, Liver Fibrosis, Cirrhosis, Liver, Blood Sugar; High
- Trial name
- GLYPP (NCT07629128)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
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