Clinical trials: Biliary Diseases
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, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
- Trial name
- NCT06778031
- Testing
- SHR-A1811, SHR-1316, SHR-8068
- Where
- 2 sites in China
- Volunteers
- 54 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Cholangiocarcinoma
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in…
- Trial name
- RELEASE (NCT04099888)
- Testing
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 41 people
- Sponsor
- PCI Biotech AS
Primary Sclerosing Cholangitis
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
- Trial name
- NCT06095986
- Testing
- Aramchol meglumine
- Where
- United States
- Sponsor
- Galmed Pharmaceuticals Ltd
Biliary Tract Cancer
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
- Trial name
- TOURMALINE (NCT05771480)
- Testing
- Durvalumab, Gemcitabine monotherapy, Gemcitabine + cisplatin
- Where
- 34 sites in United States, France and 6 more
- Volunteers
- 142 people
- Sponsor
- AstraZeneca
Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous…
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT04152018
- Testing
- PF-06940434, PF-06801591
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 85 people
- Sponsor
- Pfizer
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.
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
Primary Biliary Cirrhosis
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.
- Trial name
- NCT00746486
- Testing
- budesonide
- Where
- 2 sites in France, Germany
- Volunteers
- 62 people
- Sponsor
- Dr. Falk Pharma GmbH
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.
Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms
A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.
This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors…
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT07623642
- Testing
- GV20-0251, anti-PD-1 monoclonal antibodies
- Where
- 2 sites in China
- Volunteers
- 227 people
- Sponsor
- GV20 Therapeutics
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
Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies
This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer.
- Conditions
- Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma, Biliary Tract Cancer, Extranodal NK T Cell Lymphoma, Nasal
- Trial name
- NCT03999658
- Testing
- STI-3031
- Sponsor
- Sorrento Therapeutics, Inc.
Advanced or Metastatic Solid Tumor
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab…
- Trial name
- NCT06270706
- Testing
- PLN-101095, Pembrolizumab
- Where
- 22 sites in United States, Spain
- Volunteers
- 124 people
- Sponsor
- Pliant Therapeutics, Inc.
Biliary Tract Cancers
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)
This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with…
- Trial name
- TopDouble (NCT05924880)
- Testing
- durvalumab
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- AstraZeneca
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Cholangiocarcinoma
Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma
This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), followed by a…
- Trial name
- NCT02128282
- Testing
- CX-4945, Cisplatin, Gemcitabine
- Where
- 16 sites in United States, South Korea and 1 more
- Volunteers
- 127 people
- Sponsor
- Senhwa Biosciences, Inc.
Biliary Tract Cancer
A Trial of SHR1258 in Patients With Biliary Tract Cancer
The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with advanced/ metastatic HER2-altered biliary tract cancers
- Trial name
- NCT04571710
- Testing
- SHR1258
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.