Clinical trials: Biliary Tract
Cancer of the Bile Duct
Single Agent Regorafenib in Refractory Advanced Biliary Cancers
The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.
- Trial name
- NCT02115542
- Testing
- Regorafenib
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Primary Biliary Cholangitis
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of…
- Trial name
- NCT04620733
- Testing
- Seladelpar 10 mg, Seladelpar 5 mg
- Where
- 134 sites in United States, Argentina and 24 more
- Volunteers
- 193 people
- Sponsor
- Gilead Sciences
Biliary Tract Cancer
Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth…
- Trial name
- TreeTopp (NCT03093870)
- Testing
- Varlitinib, Capecitabine
- Where
- 21 sites in United States, Australia and 9 more
- Volunteers
- 151 people
- Sponsor
- ASLAN Pharmaceuticals
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
Cholestasis, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Gastrointestinal Cancer, Biliary Tract Cancer
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI)…
- Trial name
- NCT03531320
- Testing
- D07001-softgel capsules
- Where
- 4 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax 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.
Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma
Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery.
- Conditions
- Adult Cholangiocarcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma
- Trial name
- S1310 (NCT02042443)
- Testing
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis
- Where
- 295 sites in United States
- Volunteers
- 53 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Cancer
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
- Trial name
- NCT03639935
- Testing
- Rucaparib, Nivolumab
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Michigan Rogel Cancer Center
Metastatic Biliary Tract Carcinoma
A Phase 2 Trial of Regorafenib as A Single Agent in Advanced and Metastatic Biliary Tract Carcinoma/Cholangiocarcinoma Patients Who Have Failed First-line Chemotherapy
Based on the facts of multiple pathways involvement in cholangiocarcinoma tumor genesis, including EGFR, Ras, Raf, VEGFR, and PDGFR, with evidence of overexpression of these proteins associated with tumor stage, prognosis and…
- Trial name
- NCT02053376
- Testing
- Regorafenib
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Nathan Bahary, MD
Primary Sclerosing Cholangitis
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT04024813
- Testing
- Seladelpar
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1 people
- Sponsor
- Gilead Sciences
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Cholangiocarcinoma, Liver and Intrahepatic Bile Duct Carcinoma
Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced)…
- Conditions
- Cholangiocarcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Stage III Gallbladder Cancer AJCC v7, Stage III Intrahepatic Cholangiocarcinoma AJCC v7
- Trial name
- NCT02520141
- Testing
- Laboratory Biomarker Analysis, Ramucirumab
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- M.D. Anderson Cancer Center
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
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
Cholangitis
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis.
- Trial name
- NCT01148693
- Testing
- gentamicin
- Where
- Iran
- Volunteers
- 114 people
- Sponsor
- Tehran University of Medical Sciences
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals