Clinical trials: Biliary Tract Diseases
Alagille Syndrome
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US.
- Trial name
- NCT04530994
- Testing
- maralixibat
- Where
- 14 sites in United States
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis (PBC)
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose.
- Trial name
- NCT06798454
- Testing
- PVT201
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Parvus 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)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Cancer
A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers
This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers…
- Trial name
- NCT01943864
- Testing
- Trametinib (single tablet), Trametinib (Multiple tablet)
- Where
- 5 sites in Japan
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
Hilar Cholangiocarcinoma
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat.
- Trial name
- NCT02082522
- Testing
- Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 28 people
- Sponsor
- Concordia Laboratories Inc.
Pancreatic Neoplasms, Solid Tumors
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.
- Conditions
- Pancreatic Neoplasms, Solid Tumors, Biliary Tract Cancer, Lung Neoplasms
- Trial name
- NCT05512377
- Testing
- Brigimadlin
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 99 people
- Sponsor
- Boehringer Ingelheim
Bariatric Surgery Candidate, Cholelithiases
Clinical Evaluation of the Levita Robotic Platform
The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- NCT05353777
- Testing
- Levita Robotic Platform
- Where
- 4 sites in Chile
- Volunteers
- 48 people
- Sponsor
- Levita Magnetics
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Acute Cholecystitis, Colorectal Cancer
Safety and Feasibility of ActivSightTM in Human
ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery.
- Conditions
- Acute Cholecystitis, Colorectal Cancer, Diverticulitis, Colonic, Obesity, Morbid
- Trial name
- NCT04633512
- Testing
- ActivSight
- Where
- 3 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Where
- 4 sites in United States
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
Gallbladder Disease, Biliary Colic
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic…
- Conditions
- Gallbladder Disease, Biliary Colic, Gallstones
- Trial name
- NCT01410734
- Testing
- Indocyanine green (ICG)
- Where
- 2 sites in Italy, Switzerland
- Volunteers
- 72 people
- Sponsor
- Intuitive Surgical
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
Primary Sclerosing Cholangitis
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC).
- Trial name
- ELASCOPE (NCT07387549)
- Testing
- Elafibranor
- Where
- 231 sites in United States, Argentina and 23 more
- Volunteers
- 350 people
- Sponsor
- Ipsen
PBC, Primary Biliary Cirrhosis
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with…
- Trial name
- CLARITY (NCT01904058)
- Testing
- LUM001, Ursodeoxycholic Acid
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic…
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell
- Trial name
- NCT02443324
- Testing
- Ramucirumab, Pembrolizumab
- Where
- 22 sites in United States, France and 4 more
- Volunteers
- 175 people
- Sponsor
- Eli Lilly and Company
Bladder Cancer, Biliary Tract Cancer
ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
In DESTINY-Pan-Tumor [DP-02], DESTINY CRC02 [DC-02], and DESTINY-Lung01 [DL-01], T-DXd demonstrated tumor response across a broad range of HER2-expressing solid tumors, particularly IHC3+ patients.
- Conditions
- Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer
- Trial name
- NCT06973161
- Where
- 27 sites in United States, Austria and 10 more
- Volunteers
- 140 people
- Sponsor
- AstraZeneca
Primary Sclerosing Cholangitis
A Study of HTD1801 in Healthy Subjects
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.
- Trial name
- NCT03099603
- Testing
- HTD1801
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited