Clinical trials: Biliary Tract Diseases
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Cholelithiasis, Cholecystitis
The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy.
- Conditions
- Cholelithiasis, Cholecystitis, Pancreatitis Biliary, Colic of Gallbladder Without Mention of Cholecystitis
- Trial name
- NCT01424215
- Testing
- Indocyanine Green (ICG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Maimonides Medical Center
Parenteral Nutrition Associated Liver Disease PNALD, Cholestasis
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by…
- Trial name
- NCT00826020
- Testing
- Omegaven™
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Nebraska
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG
Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery…
- Conditions
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma
- Trial name
- NCT04941287
- Testing
- Atezolizumab, Biopsy, Biospecimen Collection
- Where
- 29 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Cancer Institute (NCI)
Cholecystitis, Hepatocellular Carcinoma
Low Dose ICG for Biliary Tract and Tumor Imaging
Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy.
- Conditions
- Cholecystitis, Hepatocellular Carcinoma, Liver Metastases
- Trial name
- ICG (NCT04942665)
- Testing
- Indocyanine green, PINPOINT Endoscopic Fluorescence
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Florida
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
Esophageal Varices
Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices
The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in…
- Trial name
- NCT06017102
- Testing
- wired magnetic assisted capsule endoscopy, esophagogastroduodenoscopy
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- National Taiwan University Hospital
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Tract Neoplasms, Liver Cancer
A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)
BACKGROUND: Various tumor ablative procedures and techniques have been shown to result in immunogenic cell death and induction of a peripheral immune response.
- Conditions
- Biliary Tract Neoplasms, Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma
- Trial name
- NCT02821754
- Testing
- Durvalumab, Tremelimumab, Trans-arterial Catheter Chemoembolization (TACE)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- National Cancer Institute (NCI)
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Biliary Tract Carcinoma
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Tract Cancer, Biliary Tract Neoplasms
Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers
This research study is designed to see if a drug called Nivolumab is effective in treating patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the U.S.
- Trial name
- NCT02829918
- Testing
- Nivolumab
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
ERCP, Pancreatic Diseases
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
- Conditions
- ERCP, Pancreatic Diseases, Bile Duct Diseases
- Trial name
- NCT00731198
- Testing
- Drotaverine hydrochloride, Hyoscine-N-butylbromide
- Where
- 4 sites in China
- Volunteers
- 650 people
- Sponsor
- Changhai Hospital
Cancer of the Liver, Liver Cancer
IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread
The working hypothesis is that oral administration of an attenuated strain of Salmonella typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a solid tumor cancer.
- Conditions
- Cancer of the Liver, Liver Cancer, Hepatoma, Liver Neoplasms
- Trial name
- NCT01099631
- Testing
- Salmonella typhimurium
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Primary Sclerosing Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT02943460
- Testing
- Cilofexor
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery.
- Conditions
- Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma
- Trial name
- S1310 (NCT02042443)
- Testing
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis
- Where
- 295 sites in United States
- Volunteers
- 53 people
- Sponsor
- National Cancer Institute (NCI)
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00789958
- Testing
- capecitabine, gemcitabine hydrochloride, 3-dimensional conformal radiation therapy
- Where
- 251 sites in United States
- Volunteers
- 105 people
- Sponsor
- SWOG Cancer Research Network