Clinical trials: Disorders of Biliary Tract
Metastatic Disease
BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients with advanced and/or metastatic…
- Trial name
- NCT01679405
- Testing
- BIBW 2992
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Johannes Gutenberg University Mainz
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
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
Hepatocellular Carcinoma
Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and…
- Trial name
- NCT00532441
- Testing
- Erlotinib, Docetaxel
- Where
- 12 sites in United States
- Volunteers
- 25 people
- Sponsor
- Gabi Chiorean, MD
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Progressive Familial Intrahepatic Cholestasis
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
Open-label extension study to evaluate long-term safety and persistence of effect of A4250 in children with progressive familial intrahepatic cholestasis (PFIC).
- Trial name
- PEDFIC 2 (NCT03659916)
- Testing
- A4250 (odevixibat)
- Where
- 41 sites in United States, Australia and 13 more
- Volunteers
- 116 people
- Sponsor
- Albireo, an Ipsen Company
Primary Sclerosing Cholangitis, Biliary Atresia
Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
The goals of the proposed work are two fold: Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC).
- Trial name
- PSC (NCT01322386)
- Testing
- Vancomycin
- Volunteers
- 32 people
- Sponsor
- Stanford University
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and…
- Trial name
- NCT00919061
- Testing
- Gemcitabine, Cisplatin, Sorafenib
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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 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
CM-101 in PSC Patients -The SPRING Study
This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT04595825
- Testing
- Anti-human CCL24 monoclonal antibody (CM-101)
- Where
- 33 sites in United States, Germany and 3 more
- Volunteers
- 77 people
- Sponsor
- ChemomAb Ltd.
Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma
MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery
This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.
- Conditions
- Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma, Recurrent Gallbladder Carcinoma
- Trial name
- NCT01425879
- Testing
- Akt Inhibitor MK2206, Diagnostic Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- National Cancer Institute (NCI)
Cholecystitis, Stomach Cancer
Effect of Modified Stylet Angulation on the Intubation With GlideScope®
The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.
- Trial name
- GlideMStylet (NCT02547064)
- Testing
- Glidescope guided intubation, GlideScope®
- Volunteers
- 162 people
- Sponsor
- Keimyung University Dongsan Medical Center
Postcholecystectomy Syndrome
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal.
- Trial name
- NCT01765465
- Testing
- Rowachol
- Where
- 2 sites in South Korea
- Volunteers
- 138 people
- Sponsor
- DongGuk University
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Biliary Tract Cancer, Gallbladder Adenocarcinoma
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or…
- Trial name
- NCT00361231
- Testing
- Bevacizumab, Gemcitabine, Oxaliplatin
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Massachusetts General Hospital
Primary Sclerosing Cholangitis
Vidofludimus Calcium for Primary Sclerosing Cholangitis
To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period.
- Trial name
- PSC (NCT03722576)
- Testing
- Vidofludimus calcium
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Elizabeth Carey
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