Clinical trials: Cholangitis
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Pruritus
J-LINX: Japan LINerixibat eXtension Study
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and…
- Trial name
- NCT07860710
- Testing
- Linerixibat
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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
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
Primary Sclerosing Cholangitis
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional…
- Trial name
- ELMWOOD (NCT05627362)
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 62 sites in United States, Canada and 5 more
- Volunteers
- 68 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
Obecholic acid is a modified bile acid and Farnesoid X receptor (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
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Primary Biliary Cholangitis
A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life
Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.
- Trial name
- OCARELIFE (NCT03703076)
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- SAMEY
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Primary Sclerosing Cholangitis
norUrsodeoxycholic Acid vs Placebo in PSC
Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment…
- Trial name
- NCT03872921
- Testing
- norUrsodeoxycholic Acid
- Where
- 2 sites in Austria, Germany
- Volunteers
- 303 people
- Sponsor
- Dr. Falk Pharma GmbH
Primary Sclerosing Cholangitis
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC).
- Trial name
- NCT05866809
- Testing
- HK-660S
- Where
- 4 sites in South Korea
- Volunteers
- 23 people
- Sponsor
- CuromeBiosciences
Healthy Volunteers, Primary Sclerosing Cholangitis
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781.
- Trial name
- NCT07229911
- Testing
- TAK-781
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Takeda
Primary Sclerosing Cholangitis
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
- Trial name
- PRIMIS (NCT03890120)
- Testing
- Cilofexor
- Where
- 201 sites in United States, Australia and 14 more
- Volunteers
- 419 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT04024813
- Testing
- Seladelpar
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.
- Trial name
- ALPINE-PSC (NCT06654726)
- Testing
- aldafermin
- Sponsor
- NGM Biopharmaceuticals, Inc
Infection
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections…
- Trial name
- NCT01670435
- Testing
- Ciprofloxacin (BAYQ3939)
- Where
- Japan
- Volunteers
- 3,274 people
- Sponsor
- Bayer
Cholangiocarcinoma, Bile Duct Inflammation
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer.
- Trial name
- FOCUS (NCT01392274)
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 121 people
- Sponsor
- Mauna Kea Technologies
Liver Diseases, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Multiparametric MRI
This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS…
- Conditions
- Liver Diseases, Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- Trial name
- NCT03743272
- Testing
- LiverMultiScan
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Perspectum
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.