Clinical trials: Biliary Tract Diseases
Gastric Adenocarcinoma, Advanced Pancreatic Ductal Adenocarcinoma
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
- Conditions
- Gastric Adenocarcinoma, Advanced Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma, Biliary Tract Cancer
- Trial name
- NCT07021066
- Testing
- BL-M05D1
- Where
- 11 sites in United States
- Volunteers
- 160 people
- Sponsor
- SystImmune Inc.
Primary Sclerosing Cholangitis
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT05642468
- Testing
- Ritivixibat
- Where
- 8 sites in France, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Albireo, an Ipsen Company
Gastric Cancer, Pancreatic Cancer
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Trial name
- CLIO (NCT02446379)
- Testing
- The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, EnLightTM, LightPathTM Imaging System
- Where
- Hungary
- Sponsor
- Lightpoint Medical Limited
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
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
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Biliary Tract Cancer
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
- Trial name
- NCT00380588
- Testing
- gemcitabine, cisplatin
- Where
- 7 sites in Japan
- Volunteers
- 84 people
- Sponsor
- Eli Lilly and Company
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.
Sepsis, Community-acquired Pneumonia
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
- Conditions
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute
- Trial name
- NCT04612413
- Testing
- Allocetra-OTS
- Where
- 31 sites in Belgium, France and 3 more
- Volunteers
- 148 people
- Sponsor
- Enlivex Therapeutics Ltd.
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
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04837508
- Testing
- MRG002
- Where
- 7 sites in China
- Volunteers
- 86 people
- Sponsor
- Shanghai Miracogen Inc.
PBC, Primary Biliary Cirrhosis
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with…
- Trial name
- CLARITY (NCT01904058)
- Testing
- LUM001, Ursodeoxycholic Acid
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Trial name
- NCT04450732
- Testing
- GQ1001
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 96 people
- Sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
Malignant Mesothelioma, Colorectal Cancer
Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors
This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802…
- Conditions
- Malignant Mesothelioma, Colorectal Cancer, Bile Duct Cancer, Rectal Cancer
- Trial name
- NCT06256055
- Testing
- UCMYM802 Injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- UTC Therapeutics Inc.
Advanced Solid Tumor, Cholangiocarcinoma
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and…
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, Biliary Tract Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05253053
- Testing
- TT-00420, Combination Product: Atezolizumab, Combination Product: Nab-Paclitaxel
- Where
- 9 sites in China
- Volunteers
- 84 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Biliary Tract Cancer
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
- Trial name
- NCT02966821
- Testing
- Surufatinib
- Where
- 5 sites in China
- Volunteers
- 39 people
- Sponsor
- Hutchison Medipharma Limited
Biliary Tract Neoplasms
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants…
- Trial name
- KN035-BTC (NCT03478488)
- Testing
- KN035 plus Gemcitabine & oxaliplatin, Gemcitabine & oxaliplatin
- Where
- China
- Volunteers
- 472 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.