Clinical trials: Disorders of Biliary Tract
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Biliary Tract Disease
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy…
- Trial name
- SPYDS (NCT02524418)
- Testing
- Cholangiopancreatoscopy
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Florida
Pancreatic Neoplasms, Bile Duct Neoplasms
CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers.
- Trial name
- NCT00634751
- Testing
- Oxaliplatin, Capecitabine, Sorafenib
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Wisconsin, Madison
Primary Sclerosing Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT02943460
- Testing
- Cilofexor
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Biliary Atresia
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
- Trial name
- EMBARK (NCT04524390)
- Testing
- Maralixibat
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 75 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Gallbladder Disease
Effect IV Ibuprofen and Inflammatory Responses
This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation.
- Trial name
- NCT01938040
- Testing
- ibuprofen
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Medicine and Dentistry of New Jersey
Cholangiocarcinoma
Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy.
- Trial name
- PrE0204 (NCT02181634)
- Testing
- Nab-Paclitaxel and Gemcitabine
- Where
- 25 sites in United States, Austria
- Volunteers
- 74 people
- Sponsor
- PrECOG, LLC.
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
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
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
Primary Sclerosing Cholangitis
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT05642468
- Testing
- Ritivixibat
- Where
- 8 sites in France, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Albireo, an Ipsen Company
Primary Sclerosing Cholangitis
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT03394781
- Testing
- DUR-928
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Durect
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Pentoxifylline for Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.
- Trial name
- NCT01249092
- Testing
- Pentoxifylline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Advanced Biliary Tract Cancer
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and…
- Trial name
- NCT04005339
- Testing
- Nanoliposomal Irinotecan, Leucovorin, Fluorouracil
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Georgetown University
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.