Clinical trials: Biliary Disease Tract
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Cholangiopancreatography, Endoscopic Retrograde, Biliary Stricture
Prospective Evaluation of Biliary Tissue Sampling With ERCP
The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies…
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Biliary Stricture, Biliary Tract Diseases, Cholangiocarcinoma
- Trial name
- NCT04572711
- Where
- United States
- Volunteers
- 327 people
- Sponsor
- Mayo Clinic
Primary Biliary Cholangitis (PBC)
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response…
- Trial name
- NCT03124108
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 45 people
- Sponsor
- Genfit
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
Biliary Tract Cancer, Gallbladder Cancer
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer
The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy.
- Trial name
- UGIH09067 (NCT01308840)
- Testing
- Panitumumab, oxaliplatin, gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- University of Rochester
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
Parenteral Nutrition Associated Cholestasis
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Trial name
- NCT01601652
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Arthur J De Lorimier
Other Acute Illnesses Presenting to the Hospital, Heart Failure
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
This VA QUERI Partnered Evaluation Initiative will evaluate the impact of an immersive Point-of-care Ultrasound (POCUS) Training Course on provider skill acquisition and retention; the frequency of POCUS use by trained providers…
- Conditions
- Other Acute Illnesses Presenting to the Hospital, Heart Failure, Pneumonia, Deep Venous Thrombosis
- Trial name
- NCT03296280
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Primary Sclerosing Cholangitis (PSC)
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and…
- Trial name
- AESOP (NCT02177136)
- Testing
- Obeticholic Acid (OCA)
- Where
- 36 sites in United States, Italy
- Volunteers
- 77 people
- Sponsor
- Intercept Pharmaceuticals
Primary Sclerosing Cholangitis
Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.
- Trial name
- NCT00953615
- Testing
- Thalidomide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mayo Clinic
Cholestasis, Jaundice, Obstructive
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.
- Trial name
- NCT02721277
- Testing
- SMOFlipid
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Florida
Primary Biliary Cirrhosis
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT00364819
- Testing
- rituximab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
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
Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer
Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers
This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers.
- Conditions
- Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder
- Trial name
- NCT01229111
- Testing
- cediranib maleate, oxaliplatin, leucovorin calcium
- Where
- 7 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Cancer Institute (NCI)
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v7
TAS-102 in Treating Advanced Biliary Tract Cancers
This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body.
- Conditions
- Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7
- Trial name
- NCT03278106
- Testing
- Laboratory Biomarker Analysis, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Mayo Clinic
Pancreaticobiliary Reflux
Pancreaticobiliary Reflux in Patients Without Cholelithiasis
Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union.
- Trial name
- NCT00890201
- Testing
- Gallbladder bile sampling and intraoperative cholangiography
- Where
- Chile
- Volunteers
- 197 people
- Sponsor
- Cirujanos la Serena
Biliary Tract Neoplasms
Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer
The purpose of this trial is to evaluate the effect of investigational drug nivolumab in combination with either gemcitabine/cisplatin chemotherapy, or in combination with another investigational agent ipilimumab in patients with…
- Trial name
- NCT03101566
- Testing
- Gemcitabine, Cisplatin, Ipilimumab
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- University of Michigan Rogel Cancer Center
Bile Duct Carcinoma, Gallbladder Carcinoma
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP).
- Conditions
- Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT04740164
- Testing
- Endoscopic Retrograde Cholangiopancreatography
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- M.D. Anderson Cancer Center
Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD).
- Conditions
- Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Trial name
- NCT01134276
- Testing
- biliary drainage
- Where
- South Korea
- Volunteers
- 211 people
- Sponsor
- Seoul National University Hospital