Clinical trials: Biliary Diseases
Solid Tumors, Head and Neck Carcinoma
Milademetan in Advanced/Metastatic Solid Tumors
Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that…
- Conditions
- Solid Tumors, Head and Neck Carcinoma, Cholangiocarcinoma, Sarcoma
- Trial name
- NCT05012397
- Testing
- RAIN-32
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rain Oncology Inc
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholecystitis
Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers
Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers
- Trial name
- NCT06315387
- Testing
- 4-MUST, 1 tablet, 4-MUST, 2 tablets, 4-MUST, 3 tablets
- Where
- Russia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Biliary Tract Cancer
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC).
- Trial name
- NCT07450976
- Testing
- SHR-A1904 for Injection
- Where
- 2 sites in China
- Volunteers
- 151 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Trial name
- NCT05775159
- Testing
- Volrustomig, Bevacizumab, Lenvatinib
- Where
- 46 sites in United States, China and 7 more
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Primary Sclerosing Cholangitis, PSC
Quantitative Magnetic Resonance Imaging in Biliary Disease: Health Economics Study
This is a health economic study on using quantitative magnetic resonance imaging in biliary disease. It is an observational study aiming to recruit 40 patients with Primary Sclerosing Cholangitis (PSC) in 12 months.
- Trial name
- BISECT (NCT04015310)
- Testing
- Quantitative Multi parametric MRI and enhanced MRCP
- Sponsor
- Perspectum
Bladder Carcinoma, Prostate Tumor
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit.
- Conditions
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma, Endometrial Carcinoma
- Trial name
- REMOVE (NCT06789224)
- Testing
- CATUVAB
- Where
- 6 sites in Germany
- Volunteers
- 136 people
- Sponsor
- Lindis Bloodcare GmbH
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC)
Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD).
- Conditions
- Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC), Colorectal Neoplasms, Colorectal Cancer
- Trial name
- OCEANIA (NCT01819766)
- Where
- 26 sites in United States, Canada
- Volunteers
- 440 people
- Sponsor
- Exact Sciences Corporation
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
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
- Trial name
- ELFINITY (NCT06447168)
- Where
- 72 sites in United States, Australia and 9 more
- Volunteers
- 424 people
- Sponsor
- Ipsen
Biliary Tract Cancer
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or…
- Trial name
- NCT07582315
- Testing
- BL-B01D1, Oxaliplatin, Calcium levofolinate
- Where
- China
- Volunteers
- 538 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C).
- Conditions
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
- Trial name
- NCT04956640
- Testing
- LY3537982, Pembrolizumab, Cetuximab
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 540 people
- Sponsor
- Eli Lilly and Company
Biliary Tract Cancer
A Study to Evaluate the Association of Biliary Complications and Treatment Duration in Unresectable BTC Patients
This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan.
- Trial name
- ARCBile (NCT07101874)
- Where
- 22 sites in Japan
- Volunteers
- 729 people
- Sponsor
- AstraZeneca
Gallstone Disease, Obstructive Jaundice
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive…
- Trial name
- NCT05928286
- Testing
- Remaxol
- Where
- 9 sites in Russia
- Volunteers
- 286 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company