Clinical trials: Bile Duct Disease
Biliary Tract Cancer
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
- Trial name
- NCT00090025
- Testing
- becatecarin, 5-Fluorouracil Plus Leucovorin
- Where
- 59 sites in United States, Belgium and 9 more
- Volunteers
- 248 people
- Sponsor
- Helsinn Healthcare SA
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
Cholestasis
Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Absorption, metabolism and excretion of linerixibat have been studied in previous clinical trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion have been conducted for linerixibat.
- Trial name
- NCT03992014
- Testing
- Linerixibat tablet, [14C]-linerixibat intravenous infusion, Linerixibat oral solution
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
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 Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Pancreatic Neoplasms, Cholestasis
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubinemia secondary to bile…
- Trial name
- NCT02267707
- Testing
- nab-paclitaxel, Gemcitabine
- Where
- 6 sites in United States, Germany
- Volunteers
- 1 people
- Sponsor
- Celgene
Cancer
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00101972
- Testing
- monoclonal antibody RAV12
- Where
- 5 sites in United States
- Volunteers
- 53 people
- Sponsor
- MacroGenics
Colorectal Cancer, Esophagus Cancer
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA…
- Conditions
- Colorectal Cancer, Esophagus Cancer, Gastric Cancer, Pancreas Cancer
- Trial name
- NCT06043466
- Testing
- CEA-targeted CAR-T cells
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Primary Biliary Cholangitis
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects…
- Trial name
- NCT05190523
- Testing
- ASC42 5 mg, ASC42 10 mg, ASC42 15 mg
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Gannex Pharma Co., Ltd.
Cancer, All Types, Cancer of Liver
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any…
- Conditions
- Cancer, All Types, Cancer of Liver, Cancer of Stomach, Cancer of Head and Neck
- Trial name
- PIONEER (NCT03896958)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- SpeciCare
Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
The purpose of this prospective randomized trial is to study the role of Indocyanine green (ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis.
- Conditions
- Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction
- Trial name
- NCT04624841
- Testing
- Indocyanine Green
- Where
- Qatar
- Volunteers
- 80 people
- Sponsor
- Hamad Medical Corporation
Cholangiocarcinoma
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure…
- Trial name
- NCT05874414
- Testing
- GNS561 + Trametinib
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 98 people
- Sponsor
- Genfit
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Solid Tumors With PTCH1 Loss-of-function Mutations
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF)…
- Trial name
- NCT05199584
- Testing
- ENV-101 (taladegib)
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Biomedicines, Inc.
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
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
Chronic Cholecystitis, Biliary Dyskinesia
Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia
The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.
- Trial name
- NCT07595003
- Testing
- 4-MUST
- Where
- 10 sites in Russia
- Volunteers
- 300 people
- Sponsor
- Valenta Pharm JSC
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex