Clinical trials: Biliary Diseases
Primary Biliary Cholangitis (PBC)
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose.
- Trial name
- NCT06798454
- Testing
- PVT201
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.
MTAP-deleted Solid Tumors
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have…
- Trial name
- NCT06188702
- Testing
- S095035, TNG462
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Servier Bio-Innovation LLC
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Appendicitis, Cholecystitis
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal…
- Conditions
- Appendicitis, Cholecystitis, Cross Infection, Diverticulitis
- Trial name
- NCT00195351
- Testing
- tigecycline, ceftriaxone sodium + metronidazole
- Where
- 66 sites in United States, Argentina and 4 more
- Volunteers
- 467 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Biliary Tract Cancers (BTC)
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis.
- Trial name
- NCT06611345
- Testing
- Tumor Treating Fields, Durvalumab, Gemcitabine
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Liver Transplantation, Hepatitis
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
- Conditions
- Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
- Trial name
- NCT00080236
- Testing
- IDN-6556
- Where
- 13 sites in United States, Germany
- Volunteers
- 99 people
- Sponsor
- Conatus Pharmaceuticals Inc.
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
Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic…
- Trial name
- MTAPESTRY 103 (NCT06360354)
- Testing
- Anvumetostat, Gemcitabine, Nab-paclitaxel
- Where
- 77 sites in United States, Australia and 14 more
- Volunteers
- 120 people
- Sponsor
- Amgen
Biliary Atresia
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
- Trial name
- NCT04336722
- Testing
- Odevixibat
- Where
- 72 sites in United States, Australia and 17 more
- Volunteers
- 254 people
- Sponsor
- Albireo, an Ipsen Company
Gastric Cancer, Pancreatic Cancer
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Trial name
- CLIO (NCT02446379)
- Testing
- The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, EnLightTM, LightPathTM Imaging System
- Where
- Hungary
- Sponsor
- Lightpoint Medical Limited
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Gallstone Disease, Obstructive Jaundice
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive…
- Trial name
- NCT05928286
- Testing
- Remaxol
- Where
- 9 sites in Russia
- Volunteers
- 286 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
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
Liver Cancer, Neoplasm Metastasis
A Trial Evaluating the Pharmacokinetics and Mode of Action of EndoTAG®-1 in Tumor Patients With Hepatic Metastases
The primary objective of study CT 4003 is to assess the behavior of EndoTAG®-1 in the body (making a so-called pharmacokinetic profile). Therefore, the course of the drug in the body is examined, i.e.
- Trial name
- NCT00542048
- Testing
- EndoTAG®-1
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- MediGene
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.
Cholestasis
Linerixibat Long-term Safety, and Tolerability Study
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who…
- Trial name
- LLSAT (NCT04167358)
- Testing
- Linerixibat
- Where
- 94 sites in United States, Argentina and 15 more
- Volunteers
- 242 people
- Sponsor
- GlaxoSmithKline