Clinical trials: Disorders of Biliary Tract
Primary Sclerosing Cholangitis
Pilot Study of Fenofibrate for PSC
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
- Trial name
- NCT01142323
- Testing
- fenofibrate
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- University of Miami
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
Breast Cancer, Colon Cancer
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer.
- Conditions
- Breast Cancer, Colon Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- Trial name
- NCT02293954
- Testing
- radionuclide imaging, positron emission tomography, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- City of Hope Medical Center
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Cholangiocarcinoma, Gallbladder Cancer
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line…
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma
- Trial name
- BOLSTER (NCT05712356)
- Testing
- certepetide, Durvalumab, Cisplatin
- Where
- 19 sites in United States
- Volunteers
- 66 people
- Sponsor
- Lisata Therapeutics, Inc.
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery.
- Conditions
- Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Malignant Neoplasm, Recurrent Extrahepatic Bile Duct Cancer
- Trial name
- NCT00478140
- Testing
- trastuzumab, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Primary Sclerosing Cholangitis
Trial of High-dose Urso in Primary Sclerosing Cholangitis
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT00059202
- Testing
- Ursodeoxycholic Acid
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Biliary Atresia
N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
Biliary atresia (BA) is a devastating liver disease of infancy, characterized by bile duct obstruction leading to liver fibrosis, cirrhosis, and eventual need for transplantation in most cases.
- Trial name
- NCT03499249
- Testing
- N-Acetyl cysteine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Baylor College of Medicine
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
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Colorectal Carcinoma, Gastric Adenocarcinoma
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX).
- Conditions
- Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04430738
- Testing
- tucatinib, trastuzumab, oxaliplatin
- Where
- 27 sites in United States, Japan
- Volunteers
- 40 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Obstruction of Biliary Tree, Biliary Tract Cancer
Endoscopic Therapy of Malignant Bile Duct Strictures
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients.
- Conditions
- Obstruction of Biliary Tree, Biliary Tract Cancer, Biliary Tract Neoplasms
- Trial name
- NCT01543607
- Testing
- Radiofrequency ablation catheter (Habib EndoHBP)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Massachusetts General Hospital
Cholangiocarcinoma
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in…
- Trial name
- RELEASE (NCT04099888)
- Testing
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 41 people
- Sponsor
- PCI Biotech AS
Extrahepatic Bile Duct Cancer, Nausea
Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer
This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.
- Conditions
- Extrahepatic Bile Duct Cancer, Nausea, Vomiting, Stage II Pancreatic Cancer
- Trial name
- NCT01534637
- Testing
- aprepitant, gemcitabine hydrochloride, capecitabine
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Wake Forest University Health Sciences
Primary Sclerosing Cholangitis
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT03394781
- Testing
- DUR-928
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Durect
Bile Duct Cancer, Intrahepatic Cholangiocarcinoma
Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma
This research study is evaluating a drug called cabozantinib as a possible treatment cancer of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of the body.
- Conditions
- Bile Duct Cancer, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct
- Trial name
- NCT01954745
- Testing
- Cabozantinib
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Massachusetts General Hospital
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
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 Cancer, Bile Duct Cancer
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.
- Trial name
- EPIPD (NCT01256034)
- Testing
- Oral IMPACT
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Chiba University
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
- Trial name
- NCT00033540
- Testing
- capecitabine, gemcitabine hydrochloride
- Where
- 112 sites in United States
- Volunteers
- 57 people
- Sponsor
- SWOG Cancer Research Network