Clinical trials: Disorders of Biliary Tract
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
Advanced Solid Tumors, HER2 Mutation
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety…
- Trial name
- panSOHO (NCT06760819)
- Testing
- BAY2927088
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Solid Tumor, Biliary Tract Cancer
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors
This study consists of phase 1b and 2a to evaluate safety, Pharmacokinetics, and efficacy of TU2218 in combination with Pembrolizumab in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Trial name
- NCT05784688
- Testing
- TU2218 + KEYTRUDA® (Pembrolizumab)
- Where
- 11 sites in United States, South Korea
- Volunteers
- 140 people
- Sponsor
- TiumBio Co., Ltd.
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and 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
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Colorectal Carcinoma, Gastric Adenocarcinoma
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX).
- Conditions
- Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04430738
- Testing
- tucatinib, trastuzumab, oxaliplatin
- Where
- 27 sites in United States, Japan
- Volunteers
- 40 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to…
- Trial name
- NCT06553768
- Testing
- Maralixibat
- Where
- 23 sites in United States, Brazil and 8 more
- Volunteers
- 90 people
- Sponsor
- Mirum Pharmaceuticals, 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, 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
Primary Biliary Cholangitis, Compensated Cirrhosis
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
- Trial name
- NCT06525311
- Testing
- K-808
- Where
- 10 sites in United States, Japan
- Volunteers
- 17 people
- Sponsor
- Kowa Research Institute, Inc.
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.
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Lung Cancer, Biliary Tract Cancer
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
- Trial name
- Imfinzi PMS (NCT04068168)
- Where
- 24 sites in South Korea
- Volunteers
- 712 people
- Sponsor
- AstraZeneca
Cholestasis
Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Absorption, metabolism and excretion of linerixibat have been studied in previous clinical trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion have been conducted for linerixibat.
- Trial name
- NCT03992014
- Testing
- Linerixibat tablet, [14C]-linerixibat intravenous infusion, Linerixibat oral solution
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment.
- Trial name
- NCT07290257
- Testing
- Livmarli Oral Product
- Where
- 15 sites in Belgium, France and 6 more
- Volunteers
- 230 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Biliary Tract Cancer
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice…
- Trial name
- NCT06282575
- Testing
- Zanidatamab, Cisplatin, Gemcitabine
- Where
- 185 sites in United States, Argentina and 23 more
- Volunteers
- 286 people
- Sponsor
- Jazz Pharmaceuticals
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
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