Clinical trials: Biliary Diseases
Cancer of the Bile Duct, Gallbladder Cancer
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer
The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall…
- Trial name
- NCT00386516
- Testing
- GM-CT-01, 5-Fluorouracil
- Where
- 3 sites in United States
- Sponsor
- Galectin Therapeutics Inc.
Biliary Neoplasms, Biliary Obstruction
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.
- Conditions
- Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
- Trial name
- NCT02460432
- Testing
- Paclitaxel-eluting metal Stent, Covered Metal Stent
- Where
- 5 sites in South Korea
- Volunteers
- 106 people
- Sponsor
- Taewoong Medical Co., Ltd.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Advance Solid Tumors, Colon and Rectal Cancer
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
- Conditions
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC, Pancreatic Adenocarcinoma Advanced or Metastatic
- Trial name
- NCT07610798
- Testing
- INV-8989
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Biliary Tract Neoplasms
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers
This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients…
- Trial name
- NCT04910386
- Testing
- Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin
- Volunteers
- 126 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Intrahepatic Cholestasis of Pregnancy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Gastric/Gastroesophageal Junction Cancer, Breast Cancer
A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.
- Conditions
- Gastric/Gastroesophageal Junction Cancer, Breast Cancer, Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT07036185
- Testing
- KJ015 Injection (Subcutaneous Injection)
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
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
Biliary Tract Cancer
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
To investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing…
- Trial name
- NCT05835778
- Where
- 24 sites in Japan
- Volunteers
- 236 people
- Sponsor
- AstraZeneca
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 Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.
- Trial name
- ALPINE-PSC (NCT06654726)
- Testing
- aldafermin
- Sponsor
- NGM Biopharmaceuticals, Inc
Cholecystitis
Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of…
- Trial name
- NCT06342804
- Testing
- 4-MUST, 2 tablets, fasted, 4-MUST, 2 tablets, after meals
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
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
Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma
A Study on Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Patients With Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma
A single-arm, open-label clinical trial, focus on the safety and efficacy of TQB2450 injection combined with Anlotinib hydrochloride capsule in patients with advanced biliary adenocarcinoma/hepatocellular carcinoma
- Trial name
- NCT03825705
- Testing
- TQB2450 injection, Anlotinib
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Sclerosing Cholangitis (PSC)
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
- Trial name
- NCT03333928
- Testing
- HTD1801
- Where
- 26 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult
- Trial name
- NCT07020221
- Testing
- VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 616 people
- Sponsor
- Verastem, Inc.
Irritable Bowel Syndrome, Gallstone Disease
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in…
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia
- Trial name
- NCT07421011
- Testing
- Trimedat®
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Primary Sclerosing Cholangitis
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC).
- Trial name
- NCT05866809
- Testing
- HK-660S
- Where
- 4 sites in South Korea
- Volunteers
- 23 people
- Sponsor
- CuromeBiosciences