Clinical trials: Disorders of Biliary Tract
Biliary Tract Cancer
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
- Trial name
- NCT00380588
- Testing
- gemcitabine, cisplatin
- Where
- 7 sites in Japan
- Volunteers
- 84 people
- Sponsor
- Eli Lilly and Company
Intrahepatic Cholestasis of Pregnancy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Cancer, Solid Tumor
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
The purpose of this study is to determine the safety and tolerability of RXC004 as monotherapy and in combination with Nivolumab in patients with advanced malignancies.
- Trial name
- NCT03447470
- Testing
- RXC004, Nivolumab
- Where
- 5 sites in United Kingdom
- Volunteers
- 46 people
- Sponsor
- Redx Pharma Ltd
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
Primary Sclerosing Cholangitis (PSC)
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
- Trial name
- CAMEO (NCT02061540)
- Testing
- LUM001
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Primary Sclerosing Cholangitis
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02653625
- Testing
- Cenicriviroc 150 mg
- Where
- 9 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- Tobira Therapeutics, Inc.
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
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
Covid19, Appendicitis
Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to…
- Conditions
- Covid19, Appendicitis, Cholecystitis, Acute, Cholecystitis; Gallstone
- Trial name
- NCT04748120
- Testing
- Operative management, Non-operative management
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The Cleveland Clinic
Prostate Cancer, Cholelithiases
A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System
The goal of this clinical trial is to test the safety and effectiveness of the Medtronic Hugo™ RAS System in patients undergoing a prostatectomy or a cholecystectomy.
- Conditions
- Prostate Cancer, Cholelithiases, Cholecystitis, Gallbladder Polyp
- Trial name
- NCT05715827
- Testing
- RAS prostatectomy and RAS cholecystectomy
- Where
- South Korea
- Volunteers
- 42 people
- Sponsor
- Medtronic - MITG
Disorders of the Pancreas and Biliary Tree
The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the pancreaticobiliary system is done indirectly by radiologic means.
- Trial name
- NCT00861198
- Testing
- ERCP as per medical indication
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- University of Florida
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholecystitis
FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or…
- Trial name
- NCT00590395
- Testing
- 18FDG (an FDA-approved radiopharmaceutical)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Alan D. Waxman, M.D.
Primary Sclerosing Cholangitis
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).
- Trial name
- NCT02978339
- Testing
- Curcumin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- John E. Eaton
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
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
Cholestasis
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions.
- Trial name
- NCT02357576
- Testing
- Intralipid 20% I.V. Fat Emulsion
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Michigan
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