Clinical trials: Biliary Tract Diseases
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states.
- Trial name
- NCT02200029
- Testing
- Ademetionine IV+tablet, Ademetionine tablet
- Where
- 12 sites in Russia
- Volunteers
- 75 people
- Sponsor
- Abbott
Primary Sclerosing Cholangitis
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible…
- Trial name
- VISTAS (NCT04663308)
- Testing
- Volixibat
- Where
- 103 sites in United States, Argentina and 12 more
- Volunteers
- 182 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Laparoscopic Cholecystectomy
Effectiveness and Safety of LED Light Source System for Endoscope
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the…
- Trial name
- ENV (NCT04561583)
- Testing
- LED light source system for endoscope, Pinpoint Endoscopic Fluorescence Imaging System
- Where
- 4 sites in China
- Sponsor
- Stryker Orthopaedics
Breast Cancer, Prostate Cancer
Tempus Priority Study: A Pan-tumor Observational Study
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with…
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer
- Trial name
- NCT05179824
- Testing
- Observation
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tempus AI
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
Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer
A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162). This study has 3 parts.
- Conditions
- Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer
- Trial name
- NCT00959127
- Testing
- ARRY-438162 (MEK162), MEK inhibitor; oral
- Where
- 10 sites in United States
- Volunteers
- 93 people
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Chronic Cholecystitis, Biliary Dyskinesia
Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers
This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128…
- Trial name
- NCT07594977
- Testing
- 4-MUST
- Where
- Russia
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Gastric Cancer, Gastroesophageal Junction Cancer
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced…
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT06219941
- Testing
- AZD0901, 5-Fluorouracil, Leucovorin
- Where
- 52 sites in United States, Australia and 12 more
- Volunteers
- 226 people
- Sponsor
- AstraZeneca
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 Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Solid Tumours
Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors
This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This study is designed to identify recommended doses and regimens in Japanese subjects for the future development of GSK1120212.
- Trial name
- NCT01324258
- Testing
- GSK1120212, Gemcitabine
- Where
- 2 sites in Japan
- Volunteers
- 19 people
- Sponsor
- GlaxoSmithKline
Solid Tumor, Solid Carcinoma
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV)…
- Conditions
- Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer
- Trial name
- MAST (NCT05346484)
- Testing
- CF33-hNIS, Pembrolizumab, Modified FOLFOX
- Where
- 12 sites in United States, Australia
- Volunteers
- 66 people
- Sponsor
- Imugene Limited
Primary Sclerosing Cholangitis
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC).
- Trial name
- ELASCOPE (NCT07387549)
- Testing
- Elafibranor
- Where
- 231 sites in United States, Argentina and 23 more
- Volunteers
- 350 people
- Sponsor
- Ipsen
Advanced Solid Tumors
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor…
- Trial name
- NCT01938612
- Testing
- MEDI4736, tremelimumab
- Where
- 21 sites in Japan, South Korea and 1 more
- Volunteers
- 269 people
- Sponsor
- AstraZeneca
Cholecystitis; Acute, Choledocholithiasis
Early MRI in Acute GallstonE Disease
This pilot study aims to determine the utility of direct Magnetic Resonance Cholangiopancreatography (MRCP) in the assessment of suspected acute gallstone disease presentations.
- Trial name
- E-MAGED (NCT03709030)
- Testing
- magnetic resonance cholangiopancreatography (MRCP)
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Perspectum
Biliary Tract Cancer
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice…
- Trial name
- NCT06282575
- Testing
- Zanidatamab, Cisplatin, Gemcitabine
- Where
- 185 sites in United States, Argentina and 23 more
- Volunteers
- 286 people
- Sponsor
- Jazz Pharmaceuticals
Sepsis, Community-acquired Pneumonia
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
- Conditions
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute
- Trial name
- NCT04612413
- Testing
- Allocetra-OTS
- Where
- 31 sites in Belgium, France and 3 more
- Volunteers
- 148 people
- Sponsor
- Enlivex Therapeutics Ltd.
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.
Gallbladder Disease
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.
- Trial name
- NOTES (NCT00889928)
- Testing
- NOTES GEN 1 Toolbox
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ethicon Endo-Surgery
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
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