Clinical trials: Biliary Tract Diseases
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.
Abscess, Intra-Abdominal, Cholecystitis
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.
The primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary…
- Conditions
- Abscess, Intra-Abdominal, Cholecystitis, Wound Infections, Peritonitis
- Trial name
- NCT00463762
- Testing
- CP-75385-02 Cefoperazone/sulbactam
- Sponsor
- Pfizer
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
HER2-positive Solid Tumors, HER2-positive Breast Cancer
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
- Conditions
- HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Gastroesophageal Cancer
- Trial name
- NCT04278144
- Testing
- BDC-1001, Nivolumab
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 175 people
- Sponsor
- Bolt Biotherapeutics, Inc.
Adenocarcinoma (NOS), Anal Cancer
DESTINY-PANTUMOUR04
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease…
- Conditions
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- DP-04 (NCT07124000)
- Testing
- Trastuzumab deruxtecan
- Where
- 18 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
Biliary Tract Neoplasms
EXIBIT: Oxaliplatin in Biliary Tract Cancer
The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.
- Trial name
- NCT00174564
- Testing
- oxaliplatin
- Volunteers
- 67 people
- Sponsor
- Sanofi
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Obstruction, Bile Duct Stricture
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY…
- Conditions
- Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases
- Trial name
- NCT04929821
- Testing
- Biliary Duct Stenting
- Where
- 6 sites in Hong Kong, India and 1 more
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Bile Duct Cancer, Intrahepatic Cholangiocarcinoma
Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma
This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles.
- Trial name
- NCT03086993
- Testing
- Melphalan/HDS, Cisplatin and Gemcitabine
- Where
- 3 sites in United States
- Volunteers
- 295 people
- Sponsor
- Delcath Systems Inc.
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
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
Biliary Tract Cancer
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and…
- Trial name
- NCT02579616
- Testing
- Lenvatinib
- Where
- 7 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Eisai Co., Ltd.
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
Biliary Tract Neoplasms, Neoplasms
Evolution® Biliary Stent System Clinical Study
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary…
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases
- Trial name
- NCT01962168
- Testing
- Evolution® Biliary Stent - Uncovered
- Where
- 9 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Cook Group Incorporated
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
Bile Duct Cancer
Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.
- Trial name
- NCT05706974
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
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
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