Clinical trials: Biliary Cholestasis
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
Cholangitis, Secondary Biliary, Cholangiocarcinoma
Advanced Endoscopy During COVID-19
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.
- Conditions
- Cholangitis, Secondary Biliary, Cholangiocarcinoma, Obstructive Jaundice, Pancreas Cancer
- Trial name
- NCT04385147
- Testing
- Endoscopic management according to standard of care
- Where
- 5 sites in United States, Egypt and 3 more
- Volunteers
- 670 people
- Sponsor
- Al-Azhar University
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)
Biliary Atresia, Neonatal Cholestasis
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major…
- Conditions
- Biliary Atresia, Neonatal Cholestasis, Infantile Hepatitis Syndrome
- Trial name
- NCT03842150
- Testing
- biliary atresia screen score
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
- Trial name
- NCT04047160
- Testing
- OP-724
- Where
- 2 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Kiminori Kimura, MD
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104.
- Trial name
- NCT05104853
- Testing
- CNP-104
- Where
- 19 sites in United States
- Volunteers
- 42 people
- Sponsor
- COUR Pharmaceutical Development Company, Inc.
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)
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Up to 40% of patients with PBC have an inadequate response to standard treatment with UDCA, hence bezafibrate, a PPAR-agonist is being introduced as add-on therapy in these patients.
- Trial name
- NCT04514965
- Testing
- Blood sampling, Fibroscan, Question
- Where
- 2 sites in Denmark
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Cholestasis, Liver Disease
Compassionate Use of Omegaven IV Fat Emulsion
This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver…
- Trial name
- NCT02477345
- Testing
- Omegaven IV
- Where
- United States
- Sponsor
- Northwell Health
Alagille Syndrome, Pulmonary Artery Stenoses
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
The goal of this interventional study is to test a hemostasis screening protocol and cardiac peri-procedural and post-operative hemostasis pathway to improving bleeding complications and improve patient survival for children with…
- Conditions
- Alagille Syndrome, Pulmonary Artery Stenoses, Acquired Von Willebrand Disease
- Trial name
- NCT05846854
- Testing
- Assessment for bleeding disorder with tailored post-operative care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis, Extrahepatic
EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP
Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum…
- Trial name
- NCT02103413
- Testing
- EUS-BD, PTBD
- Where
- 2 sites in South Korea
- Volunteers
- 66 people
- Sponsor
- Asan Medical Center
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
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc
Liver Disease, Cholestasis
Gabapentin to Treat Itch in Patients With Liver Disease
In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York (NY).
- Conditions
- Liver Disease, Cholestasis, Cirrhosis, Pruritus
- Trial name
- NCT00058890
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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