Clinical trials: Biliary Tract Diseases
Primary Sclerosing Cholangitis
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT04024813
- Testing
- Seladelpar
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1 people
- Sponsor
- Gilead Sciences
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.
Selected Advanced Solid Tumors, Colorectal Cancer (CRC)
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors.
- Conditions
- Selected Advanced Solid Tumors, Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07812805
- Testing
- SKL35501, SKL35502
- Where
- 5 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- SK Life Science, Inc.
Cholestasis, Intrahepatic
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease.
- Trial name
- NCT06183242
- Testing
- Remaxa, enteric-coated tablets, Remaxol
- Where
- 3 sites in Russia
- Volunteers
- 328 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Cancer, Solid Tumor
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
The purpose of this study is to determine the safety and tolerability of RXC004 as monotherapy and in combination with Nivolumab in patients with advanced malignancies.
- Trial name
- NCT03447470
- Testing
- RXC004, Nivolumab
- Where
- 5 sites in United Kingdom
- Volunteers
- 46 people
- Sponsor
- Redx Pharma Ltd
EGFR Overexpression, Locally Advanced Solid Tumor
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can…
- Conditions
- EGFR Overexpression, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT06975410
- Testing
- YH32364
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Yuhan Corporation
Obesity
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic.
- Trial name
- NCT00576589
- Testing
- CE-326,597
- Where
- 12 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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.
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
Metastatic Cancer, Solid Tumor
LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors
- Conditions
- Metastatic Cancer, Solid Tumor, Pancreatic Cancer, Urothelial Carcinoma
- Trial name
- NCT04666688
- Testing
- LYT-200, Tislelizumab, Gemcitabine/nab-paclitaxel
- Where
- 12 sites in United States
- Volunteers
- 44 people
- Sponsor
- PureTech
Cancer of Bile Duct, Pancreatic Cancer
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in…
- Trial name
- NCT01041612
- Testing
- PTFE Covered ComVi [full covered] Biliary Stent
- Where
- 13 sites in Japan, South Korea
- Volunteers
- 120 people
- Sponsor
- Taewoong Medical Co., Ltd.
Biliary Atresia
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy).
- Trial name
- NCT06121375
- Testing
- OCA
- Where
- 24 sites in Australia, Canada and 8 more
- Volunteers
- 28 people
- Sponsor
- Intercept Pharmaceuticals
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Cholangiocarcinoma, Bile Duct Inflammation
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer.
- Trial name
- FOCUS (NCT01392274)
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 121 people
- Sponsor
- Mauna Kea Technologies
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
Cholecystitis
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also…
- Trial name
- NCT05006950
- Testing
- Stryker1688 Fluorescence imaging system
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Stryker Endoscopy
Hepatitis B, Cholestasis
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
- Trial name
- NCT01998620
- Testing
- Ademetionine 2, Ademetionine 1, Ademetionine 3
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC)
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine…
- Conditions
- NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus
- Trial name
- NCT07277413
- Testing
- IDE892, IDE397
- Where
- 23 sites in United States
- Volunteers
- 260 people
- Sponsor
- IDEAYA Biosciences
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer
- Trial name
- NCT04383210
- Testing
- Seribantumab
- Where
- 42 sites in United States, Australia and 2 more
- Volunteers
- 54 people
- Sponsor
- Elevation Oncology