Clinical trials: Biliary Diseases
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C).
- Conditions
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
- Trial name
- NCT04956640
- Testing
- LY3537982, Pembrolizumab, Cetuximab
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 540 people
- Sponsor
- Eli Lilly and Company
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are…
- Conditions
- Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma, Biliary Tract Cancer
- Trial name
- NCT06451497
- Testing
- ZM008
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Zumutor Biologics Inc.
Biliary Tract Cancer
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or…
- Trial name
- NCT07582315
- Testing
- BL-B01D1, Oxaliplatin, Calcium levofolinate
- Where
- China
- Volunteers
- 538 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Biliary Tract Neoplasms, Neoplasms
Evolution® Biliary Stent System Clinical Study
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary…
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases
- Trial name
- NCT01962168
- Testing
- Evolution® Biliary Stent - Uncovered
- Where
- 9 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Cook Group Incorporated
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc
Biliary Tract Cancer
A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.
- Trial name
- NCT04329429
- Testing
- RC48-ADC
- Where
- 16 sites in China
- Volunteers
- 57 people
- Sponsor
- RemeGen Co., Ltd.
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This example phase 1/2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic…
- Conditions
- Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
- Trial name
- DUET-BTC (NCT07641036)
- Testing
- EB-HC01 dual-target CARNK cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Biotech
Primary Sclerosing Cholangitis
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.
- Trial name
- NUC-3 (NCT01755507)
- Testing
- norUDCA
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 159 people
- Sponsor
- Dr. Falk Pharma GmbH
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104.
- Trial name
- NCT05104853
- Testing
- CNP-104
- Where
- 19 sites in United States
- Volunteers
- 42 people
- Sponsor
- COUR Pharmaceutical Development Company, 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.
Biliary Tract Cancer
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
- Trial name
- AB02 (NCT07221253)
- Testing
- Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin
- Where
- 183 sites in United States, Australia and 17 more
- Volunteers
- 1,100 people
- Sponsor
- AstraZeneca
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Gallstone Disease, Obstructive Jaundice
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive…
- Trial name
- NCT05928286
- Testing
- Remaxol
- Where
- 9 sites in Russia
- Volunteers
- 286 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company