Clinical trials: Biliary Diseases
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Tract Cancer
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer
- Trial name
- NCT05429697
- Testing
- SMT-NK inj.+Pembrolizumab, Pembrolizumab
- Where
- 3 sites in South Korea
- Volunteers
- 128 people
- Sponsor
- SMT bio Co., Ltd.
MTAP-deleted Solid Tumors
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have…
- Trial name
- NCT06188702
- Testing
- S095035, TNG462
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Servier Bio-Innovation LLC
Cancer
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop…
- Trial name
- NCT00096083
- Testing
- isolated perfusion, melphalan
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Delcath Systems Inc.
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG
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
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure.
- Trial name
- NCT02006537
- Testing
- GSK2256294
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Biliary Tract Cancer
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity…
- Trial name
- NCT06938321
- Testing
- AK112, AK130
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Akeso
Biliary Tract Cancers (BTC)
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis.
- Trial name
- NCT06611345
- Testing
- Tumor Treating Fields, Durvalumab, Gemcitabine
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA
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
Primary Sclerosing Cholangitis, Compensated Cirrhosis
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
- Trial name
- NCT04060147
- Testing
- Cilofexor
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Gilead Sciences
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Cholecystitis
Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of…
- Trial name
- NCT06342804
- Testing
- 4-MUST, 2 tablets, fasted, 4-MUST, 2 tablets, after meals
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Advanced Solid Tumors, Colorectal Cancer
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
This is a Phase 1/2, open-label, multicentric, non-randomised, parallel-arm study that aims to establish the safety, tolerability, and initial efficacy of CAN04 in combination with 3 SoC chemotherapies (mFOLFOX, DTX, and G/C).
- Conditions
- Advanced Solid Tumors, Colorectal Cancer, Non Small Cell Lung Cancer, Biliary Tract Cancer
- Trial name
- NCT05116891
- Testing
- CAN04 (nadunolimab), mFOLFOX, DTX
- Where
- 6 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- Cantargia AB
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.
Infection
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily…
- Trial name
- NCT01690559
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 704 people
- Sponsor
- Bayer
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states.
- Trial name
- NCT02200029
- Testing
- Ademetionine IV+tablet, Ademetionine tablet
- Where
- 12 sites in Russia
- Volunteers
- 75 people
- Sponsor
- Abbott