Clinical trials: Disorders of Biliary Tract
Primary Sclerosing Cholangitis
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis
- Trial name
- NCT04480840
- Testing
- PLN-74809
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 121 people
- Sponsor
- Pliant Therapeutics, Inc.
Biliary Tract Cancer
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer
Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line…
- Trial name
- NCT06465563
- Testing
- SHR-8068, Adebrelimab, Cisplatin
- Where
- 2 sites in China
- Volunteers
- 93 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Primary Biliary Cholangitis
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid…
- Trial name
- HEROES-PBC (NCT05293938)
- Testing
- Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA
- Where
- United States
- Sponsor
- Intercept Pharmaceuticals
Liver Cancer, Pancreas Cancer
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers .
- Conditions
- Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
- Trial name
- NCT04014478
- Testing
- Endovascular Denervation
- Volunteers
- 110 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Biliary Tract Cancer
X-MAS Biliary Study With Covered Biliary Stent
The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree.
- Trial name
- NCT01899976
- Testing
- X-Suit NIR Covered Biliary Stent
- Where
- 9 sites in Belgium, Israel and 1 more
- Volunteers
- 68 people
- Sponsor
- Medinol Ltd.
Primary Sclerosing Cholangitis, Compensated Cirrhosis
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
- Trial name
- NCT04060147
- Testing
- Cilofexor
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Gilead Sciences
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
Biliary Tract Neoplasms
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
- Trial name
- TOPAZ-1 (NCT03875235)
- Testing
- Durvalumab
- Where
- 126 sites in United States, Argentina and 15 more
- Volunteers
- 810 people
- Sponsor
- AstraZeneca
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
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda
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
Biliary Tract Cancer, Cholangiocarcinoma
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT03833661
- Testing
- M7824
- Where
- 33 sites in United States, China and 7 more
- Volunteers
- 159 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cancer of the Liver
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population.
- Trial name
- NCT00422877
- Testing
- Taxoprexin
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- American Regent, Inc.
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are…
- Conditions
- Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma, Biliary Tract Cancer
- Trial name
- NCT06451497
- Testing
- ZM008
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Zumutor Biologics Inc.
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
KRAS G12D Mutation, Advanced Solid Cancer
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
- Trial name
- NCT07023731
- Testing
- ARV-806
- Where
- 14 sites in United States
- Volunteers
- 76 people
- Sponsor
- Arvinas Inc.
Cholelithiasis
Renalof in the Treatment of Elderly Patients With Gallstones
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65…
- Trial name
- NCT01099319
- Testing
- Renalof
- Where
- Cuba
- Volunteers
- 40 people
- Sponsor
- Catalysis SL
Adenocarcinoma (NOS), Anal Cancer
DESTINY-PANTUMOUR04
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease…
- Conditions
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- DP-04 (NCT07124000)
- Testing
- Trastuzumab deruxtecan
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals