Clinical trials: Biliary Tract
Infection
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections…
- Trial name
- NCT01670435
- Testing
- Ciprofloxacin (BAYQ3939)
- Where
- Japan
- Volunteers
- 3,274 people
- Sponsor
- Bayer
Alagille Syndrome (ALGS)
A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
The main aim of the study is to check if TAK-625 improves symptoms of Alagille Syndrome (ALGS), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543174
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Takeda
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
Biliary Tract Cancer
A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy
The primary purpose of this study is to investigate the safety of Tasfygo.
- Trial name
- NCT06793709
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Eisai Co., Ltd.
Alagille Syndrome
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
- Trial name
- NCT07585097
- Where
- 14 sites in France, Italy
- Volunteers
- 30 people
- Sponsor
- Ipsen
Advanced Solid Tumors, Ewing Sarcoma
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
- Conditions
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07197554
- Testing
- ST-01156
- Where
- 6 sites in United States
- Volunteers
- 171 people
- Sponsor
- SEED Therapeutics, Inc.
Breast Cancer, Prostate Cancer
Tempus Priority Study: A Pan-tumor Observational Study
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with…
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer
- Trial name
- NCT05179824
- Testing
- Observation
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tempus AI
Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
- Trial name
- BOLD-EXT (NCT05426733)
- Testing
- Odevixibat
- Where
- 30 sites in United States, Australia and 12 more
- Volunteers
- 180 people
- Sponsor
- Albireo, an Ipsen Company
Advanced Endstage Solid Carcinomas in Adults
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with Non-Small Cell Lung Carcinoma…
- Trial name
- CAP7-1 (NCT02094560)
- Testing
- CAP7.1
- Where
- Germany
- Volunteers
- 45 people
- Sponsor
- CellAct Pharma GmbH
Cancer Harboring BRAF Alterations, HGG
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive…
- Conditions
- Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
- Trial name
- NCT05503797
- Testing
- Plixorafenib
- Where
- 70 sites in United States, Australia and 10 more
- Volunteers
- 254 people
- Sponsor
- Fore Biotherapeutics
Primary Sclerosing Cholangitis, Cholangitis
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
- Conditions
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases
- Trial name
- NCT03678480
- Testing
- HTD1801, Ursodeoxycholic Acid
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
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.
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.
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
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
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, 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
Progressive Familial Intrahepatic Cholestasis
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
Open-label extension study to evaluate long-term safety and persistence of effect of A4250 in children with progressive familial intrahepatic cholestasis (PFIC).
- Trial name
- PEDFIC 2 (NCT03659916)
- Testing
- A4250 (odevixibat)
- Where
- 41 sites in United States, Australia and 13 more
- Volunteers
- 116 people
- Sponsor
- Albireo, an Ipsen Company
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda