Clinical trials: Disorders of Biliary Tract
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Neoplasms, Solid Tumors
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available…
- Conditions
- Neoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer
- Trial name
- NCT02091141
- Testing
- Trastuzumab, Pertuzumab, Erlotinib
- Where
- 60 sites in United States
- Volunteers
- 673 people
- Sponsor
- Genentech, Inc.
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Chronic Cholecystitis, Biliary Dyskinesia
Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
- Trial name
- NCT06842966
- Testing
- 4-MUST
- Where
- 17 sites in Russia
- Volunteers
- 300 people
- Sponsor
- Valenta Pharm JSC
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.
Biliary Tract Cancer
A Trial of SHR1258 in Patients With Biliary Tract Cancer
The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with advanced/ metastatic HER2-altered biliary tract cancers
- Trial name
- NCT04571710
- Testing
- SHR1258
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Cancer, Anal Carcinoma
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
- Conditions
- Advanced Cancer, Anal Carcinoma, Anal Cancer, Biliary Cancer
- Trial name
- NCT02628067
- Testing
- pembrolizumab
- Volunteers
- 1,609 people
- Sponsor
- Merck Sharp & Dohme LLC
Cancer of the Liver
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract
To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population.
- Trial name
- NCT00422877
- Testing
- Taxoprexin
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- American Regent, Inc.
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
Cholangiocarcinoma
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure…
- Trial name
- NCT05874414
- Testing
- GNS561 + Trametinib
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 98 people
- Sponsor
- Genfit
Primary Sclerosing Cholangitis
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis
- Trial name
- NCT04480840
- Testing
- PLN-74809
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 121 people
- Sponsor
- Pliant Therapeutics, Inc.
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)
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- KEYNOTE-966 (NCT04003636)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 185 sites in United States, Argentina and 22 more
- Volunteers
- 1,069 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Cancer, Solid Tumor
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by…
- Trial name
- NCT04641871
- Testing
- Sym021, Sym022, Sym023
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 78 people
- Sponsor
- Symphogen A/S
Biliary Tract Diseases
Spy II Clinical Registry
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
- Trial name
- NCT00751998
- Testing
- SpyGlass
- Where
- 15 sites in United States, Belgium and 4 more
- Volunteers
- 297 people
- Sponsor
- Boston Scientific Corporation
Biliary Tract Cancer, Melanoma
HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma
- Trial name
- NCT06708663
- Testing
- HX009+IN10018
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
Primary Biliary Cholangitis
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).
- Trial name
- IDEAL (NCT06060665)
- Testing
- Seladelpar 10 mg
- Where
- 45 sites in United States, Canada
- Volunteers
- 96 people
- Sponsor
- Gilead Sciences
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
HER2-Expressing Solid Tumors
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors.
- Trial name
- NCT07334119
- Testing
- MT-304, MT-304 + Nivolumab
- Where
- 7 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Myeloid Therapeutics
Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
- Trial name
- BOLD-EXT (NCT05426733)
- Testing
- Odevixibat
- Where
- 30 sites in United States, Australia and 12 more
- Volunteers
- 180 people
- Sponsor
- Albireo, an Ipsen Company