Clinical trials: Disorders of Biliary Tract
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Liver Cirrhosis, Biliary
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
- Trial name
- NCT00570765
- Testing
- Obeticholic Acid (OCA)
- Where
- 21 sites in United States, Austria and 5 more
- Volunteers
- 60 people
- Sponsor
- Intercept Pharmaceuticals
Acute Cholecystitis, Cholecystectomy
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
- Trial name
- NCT01548339
- Testing
- Laparoscopic cholecystectomy
- Where
- Switzerland
- Volunteers
- 86 people
- Sponsor
- University of Lausanne Hospitals
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
Progressive Familial Intrahepatic Cholestasis (PFIC)
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX).
- Trial name
- INDIGO (NCT02057718)
- Testing
- LUM001 (Maralixibat)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholelithiasis, Ultrasonography
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
The objective of this study is to prospectively compare laparoscopic ultrasound to transabdominal ultrasound for the detection of gallbladder pathology in obese patients presenting for laparoscopic gastric bypass.
- Conditions
- Cholelithiasis, Ultrasonography, Laparoscopic Gastric Bypass
- Trial name
- NCT00971750
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Gundersen Lutheran Medical Foundation
Extrahepatic Bile Duct Adenocarcinoma, Gallbladder Adenocarcinoma
Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma.
- Conditions
- Extrahepatic Bile Duct Adenocarcinoma, Gallbladder Adenocarcinoma, Gallbladder Adenocarcinoma With Squamous Metaplasia, Hilar Cholangiocarcinoma
- Trial name
- NCT01093222
- Testing
- Erlotinib Hydrochloride, Sorafenib Tosylate
- Where
- 141 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Diseases, Stomach Neoplasms
An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
Purpose: To assess the utility of a new medical device that monitors a patient's breathing during medical procedures in which a patient is sedated, but not mechanically ventilated.
- Conditions
- Biliary Tract Diseases, Stomach Neoplasms, Carcinoma, Pancreatic Ductal, Barrett Esophagus
- Trial name
- NCT02310230
- Testing
- ExSpiron Respiratory Variation Monitor
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Donald Mathews
Biliary Atresia
A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to evaluate whether long-term treatment with corticosteroids improves the outcome of the Kasai or gall-bladder Kasai in infants…
- Trial name
- NCT00294684
- Testing
- Corticosteroids
- Where
- 14 sites in United States
- Volunteers
- 141 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations.
- Conditions
- Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation, Metastatic Bile Duct Carcinoma, PTEN Gene Deletion
- Trial name
- NCT04042831
- Testing
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- Academic and Community Cancer Research United
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
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
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Colorectal Cancer, Depression
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
RATIONALE: Escitalopram may help improve depression and quality of life in patients with advanced lung or gastrointestinal cancer.
- Conditions
- Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer
- Trial name
- NCT00387348
- Testing
- escitalopram oxalate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Pancreatic Cancer, Biliary Cancer
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers leading to responses in a substantial minority and increasing survival.
- Trial name
- NCT01661114
- Testing
- Gemcitabine, 5-FU, Cisplatin
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Michigan Rogel Cancer Center
Primary Biliary Cirrhosis (PBC)
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT02609048
- Testing
- Experimental: Seladelpar 50 mg, Experimental: Seladelpar / MBX-8025 200 mg
- Where
- 49 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
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