Clinical trials: Biliary Cholestasis
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.
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.
Pancreatic Diseases, Bile Duct Obstruction
SpyGlass™ Discover Percutaneous
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
- Conditions
- Pancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases
- Trial name
- NCT04580940
- Testing
- SpyGlass™ Discover Digital System
- Where
- 7 sites in United States, Belgium and 5 more
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
- Trial name
- NCT06427395
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- 28 sites in United States, Argentina and 1 more
- Volunteers
- 102 people
- Sponsor
- Zydus Therapeutics Inc.
Liver Cirrhosis, Biliary
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
BCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary cholangitis (PBC).
- Trial name
- NCT03476993
- Testing
- BCD-085
- Where
- 3 sites in Russia
- Volunteers
- 9 people
- Sponsor
- Biocad
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
PFIC - Progressive Familial Intrahepatic Cholestasis
A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain
Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of inherited conditions that affect how bile moves in the liver, which can lead to serious liver problems.
- Trial name
- REGENIC (NCT07191704)
- Where
- 10 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Ipsen
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Primary Biliary Cholangitis
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- EPICS-III (NCT05133336)
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- 57 sites in United States, Argentina and 2 more
- Volunteers
- 196 people
- Sponsor
- Zydus Therapeutics Inc.
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Carcinomas/Neoplasms
Evolution® Biliary Stent System-Fully Covered
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms…
- Trial name
- NCT02104076
- Testing
- Evolution® Biliary Stent-Fully Covered
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Cook Group Incorporated
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.
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
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.
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.
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
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