Clinical trials: Biliary Tract Diseases
Cholelithiasis
Renalof in the Treatment of Elderly Patients With Gallstones
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65…
- Trial name
- NCT01099319
- Testing
- Renalof
- Where
- Cuba
- Volunteers
- 40 people
- Sponsor
- Catalysis SL
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Uterine Cervical Neoplasms, Endometrial Neoplasms
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected…
- Conditions
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms
- Trial name
- NCT05007106
- Testing
- Pembrolizumab/Vibostolimab Co-Formulation, Pembrolizumab, Lenvatinib
- Where
- 73 sites in United States, Canada and 13 more
- Volunteers
- 611 people
- Sponsor
- Merck Sharp & Dohme LLC
Pancreatic Diseases, Bile Duct Diseases
SpyGlass Surgical Study
To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope To identify specific surgical procedures in which intraoperative use of a thin…
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Trial name
- NCT05822635
- Testing
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Where
- 5 sites in United States, China and 2 more
- Volunteers
- 34 people
- Sponsor
- Boston Scientific Corporation
Primary Biliary Cholangitis
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT03155932
- Testing
- APD334
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 2 people
- Sponsor
- Arena Pharmaceuticals
Primary Biliary Cholangitis
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.
- Trial name
- NCT07049887
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
Biliary Tract Cancer
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
- Trial name
- NCT00090025
- Testing
- becatecarin, 5-Fluorouracil Plus Leucovorin
- Where
- 59 sites in United States, Belgium and 9 more
- Volunteers
- 248 people
- Sponsor
- Helsinn Healthcare SA
Solid Tumor
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion.
- Trial name
- NCT06336148
- Testing
- ACTM-838
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Actym Therapeutics, Inc.
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Cholecystitis; Acute, Choledocholithiasis
Early MRI in Acute GallstonE Disease
This pilot study aims to determine the utility of direct Magnetic Resonance Cholangiopancreatography (MRCP) in the assessment of suspected acute gallstone disease presentations.
- Trial name
- E-MAGED (NCT03709030)
- Testing
- magnetic resonance cholangiopancreatography (MRCP)
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Perspectum
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.
- Trial name
- DPT02 (NCT04482309)
- Testing
- Trastuzumab deruxtecan
- Where
- 89 sites in United States, Australia and 15 more
- Volunteers
- 477 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer
A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after…
- Trial name
- NCT07606599
- Testing
- BL-M07D1, Oxaliplatin, Calcium levofolinate
- Where
- 2 sites in China
- Volunteers
- 398 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Endometrial Cancer, Gastric Cancer
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid…
- Conditions
- Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer
- Trial name
- NCT05489211
- Testing
- Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil
- Where
- 96 sites in United States, Canada and 12 more
- Volunteers
- 454 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced…
- Trial name
- NCT05998447
- Testing
- GEN-001, Pembrolizumab, mFOLFOX
- Where
- 6 sites in South Korea
- Volunteers
- 10 people
- Sponsor
- Genome & Company
Primary Sclerosing Cholangitis
norUrsodeoxycholic Acid vs Placebo in PSC
Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment…
- Trial name
- NCT03872921
- Testing
- norUrsodeoxycholic Acid
- Where
- 2 sites in Austria, Germany
- Volunteers
- 303 people
- Sponsor
- Dr. Falk Pharma GmbH
Cholestatic Liver Disease
MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study
Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.
- Trial name
- MERGE (NCT04168385)
- Testing
- Maralixibat
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 52 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
- Trial name
- EPICS-V (NCT07216235)
- Testing
- Saroglitazar magnesium 1 mg
- Where
- 3 sites in United States
- Volunteers
- 386 people
- Sponsor
- Zydus Therapeutics Inc.
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04838964
- Testing
- MRG003
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Gallstones
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in…
- Trial name
- NCT02325492
- Testing
- Aramchol, Ultrasound
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Galmed Pharmaceuticals Ltd