Clinical trials: Biliary Diseases
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.
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
Advanced Solid Tumors, Biliary Tract Cancer
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid…
- Trial name
- NCT03440450
- Testing
- FF-10832 Gemcitabine Liposome Injection
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma
A Study on Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Patients With Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma
A single-arm, open-label clinical trial, focus on the safety and efficacy of TQB2450 injection combined with Anlotinib hydrochloride capsule in patients with advanced biliary adenocarcinoma/hepatocellular carcinoma
- Trial name
- NCT03825705
- Testing
- TQB2450 injection, Anlotinib
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for…
- Trial name
- NCT03929666
- Testing
- ZW25 (Zanidatamab), Capecitabine, Cisplatin
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 74 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Cancer
A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer
This is a Phase Ib, open-label,single-arm, clinical study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 (PD-L1)…
- Trial name
- NCT04608786
- Testing
- ZKAB001 5mg/kg, Capecitabine
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lee's Pharmaceutical Limited
Neoplasms, Bile Duct
Feasibility of Cryobiopsy from the Bile Duct - CRYLEO
This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval.
- Trial name
- CRYLEO (NCT06249841)
- Testing
- 1.1mm flexible Cryoprobe SU
- Where
- 5 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Erbe Elektromedizin GmbH
Liver Cirrhosis, Biliary
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
- Trial name
- NCT00406237
- Testing
- tigecycline
- Where
- 3 sites in United States, Puerto Rico
- Volunteers
- 8 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Gastrointestinal Cancer, Biliary Tract Cancer
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI)…
- Trial name
- NCT03531320
- Testing
- D07001-softgel capsules
- Where
- 4 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax Inc.
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.
Advanced Gastrointestinal Tumors
Study of Minnelide™ in Patients With Advanced GI Tumors
The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol
- Trial name
- NCT01927965
- Testing
- Minnelide™ 001
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Minneamrita Therapeutics LLC
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan…
- Conditions
- Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
- Trial name
- NCT05009953
- Testing
- Irinotecan Liposome Injection, SG001, Fluorouracil
- Where
- China
- Volunteers
- 17 people
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma
AB122 Platform Study
This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.
- Conditions
- Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT04999761
- Testing
- AB122, TAS-116, TAS-120
- Where
- 9 sites in Japan
- Volunteers
- 917 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms
A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.
This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors…
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT07623642
- Testing
- GV20-0251, anti-PD-1 monoclonal antibodies
- Where
- 2 sites in China
- Volunteers
- 227 people
- Sponsor
- GV20 Therapeutics
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Biliary Tract Cancer
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC).
- Trial name
- NCT07450976
- Testing
- SHR-A1904 for Injection
- Where
- 2 sites in China
- Volunteers
- 151 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Biliary Stones
Non-Complex Biliary Stones DSC vs ERC
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic…
- Trial name
- NCT03421340
- Testing
- DSC, ERC
- Where
- 8 sites in United States, India and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Liver Cirrhosis, Biliary
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver…
- Trial name
- COBALT (NCT02308111)
- Testing
- Obeticholic Acid (OCA)
- Where
- 181 sites in United States, Argentina and 29 more
- Volunteers
- 334 people
- Sponsor
- Intercept Pharmaceuticals
Advanced or Metastatic Solid Tumor
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab…
- Trial name
- NCT06270706
- Testing
- PLN-101095, Pembrolizumab
- Where
- 22 sites in United States, Spain
- Volunteers
- 124 people
- Sponsor
- Pliant Therapeutics, Inc.