Clinical trials: Bile Duct Disease
PBC
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression
Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver…
- Trial name
- NCT07733882
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Parenteral Nutrition-Associated Liver Disease
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis.
- Trial name
- NCT02925520
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Cook Children's Health Care System
Advanced Solid Cancers
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.
- Trial name
- NCT07186842
- Testing
- BNT329, CA19-9-targeting monoclonal antibody
- Where
- 18 sites in United States, Australia and 3 more
- Volunteers
- 245 people
- Sponsor
- BioNTech SE
Primary Biliary Cirrhosis
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to several symptoms such as intractable pruritus or chronic fatigue, significantly impairing patients quality of life.
- Trial name
- NCT02557360
- Testing
- S-adenosyl-L-methionine
- Where
- 2 sites in Poland
- Volunteers
- 24 people
- Sponsor
- Pomeranian Medical University Szczecin
Chronic Pancreatitis, Inflammatory Bowel Diseases
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect…
- Conditions
- Chronic Pancreatitis, Inflammatory Bowel Diseases, Hepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- GREAT1 (NCT04306939)
- Testing
- venipuncture, Questionnaires, Additional Sample Collections
- Where
- United States
- Volunteers
- 120,000 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
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.
Biliary Atresia
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure …
- Trial name
- NCT00539565
- Testing
- prednisolone
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- King's College Hospital NHS Trust
Extrahepatic Cholangiocarcinoma
Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic…
- Trial name
- BRAVE (NCT07235007)
- Testing
- Endobiliary Radiofrequency Ablation (EB-RFA), Plastic Biliary Stent
- Where
- 8 sites in Japan, South Korea
- Volunteers
- 120 people
- Sponsor
- Aichi Medical University
Primary Biliary Cirrhosis
Pentoxifylline for Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.
- Trial name
- NCT01249092
- Testing
- Pentoxifylline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Biliary Atresia, Kasai Operation
Robot-assisted Modified Kasai Portoenterostomy Versus Open Kasai Portoenterostomy for Biliary Atresia
Open Kasai portoenterostomy (OKPE) is considered the standard treatment procedure for biliary atresia (BA). Robotic-assisted Kasai portoenterostomy (RAKPE) has been utilized to treat BA.
- Conditions
- Biliary Atresia, Kasai Operation, Robotic Surgery, Open Surgery
- Trial name
- RKPEVSOKPE (NCT06219993)
- Testing
- robot-assisted modified Kasai portoenterostomy, traditional open Kasai portoenterostomy
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Zunyi Medical College
Intrahepatic Cholestasis of Pregnancy
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of…
- Trial name
- NCT01898832
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Primary Sclerosing Cholangitis
Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world.
- Trial name
- CATCH-IT (NCT05462093)
- Testing
- Liver Multiscan sequences, Liver Multiscan analysis, MRCP+
- Volunteers
- 200 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Cystic Fibrosis, Gastrointestinal Diseases
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II.
- Conditions
- Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis
- Trial name
- NCT00004315
- Testing
- ursodiol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Center for Research Resources (NCRR)
Primary Biliary Cirrhosis
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
- Trial name
- NCT01857284
- Testing
- Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules
- Where
- 25 sites in China
- Volunteers
- 216 people
- Sponsor
- Beijing Friendship Hospital
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Trial name
- NCT03345589
- Testing
- 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic
- Where
- China
- Volunteers
- 40 people
- Sponsor
- West China Hospital
Choledocholithiasis
Prospective Comparison of the Carbon Footprint of EUS vs MRCP for Evaluation of Suspected Choledocholithiasis
MRCP and EUS are diagnostically equivalent in detecting CBD stones among patients with intermediate risk, as shown in a landmark RCT.
- Trial name
- NCT07283185
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Asian Institute of Gastroenterology, India
Intrahepatic Cholestases, Pregnancy Complications
Metformin in Intrahepatic Cholestasis of Pregnancy
This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.
- Trial name
- METRIC (NCT03056274)
- Testing
- Metformin, Ursodeoxycholic Acid
- Volunteers
- 40 people
- Sponsor
- Epsom and St Helier University Hospitals NHS Trust
Colorectal Liver Metastases
Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts.
- Trial name
- COLDFIRE-2 (NCT02082782)
- Testing
- Irreversible electroporation (IRE)
- Where
- 3 sites in Netherlands
- Volunteers
- 51 people
- Sponsor
- Amsterdam UMC, location VUmc
Disease of Liver and Bile Duct
Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.
- Trial name
- NCT02897908
- Testing
- vibration controlled transient elastography (VCTE)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- State University of New York at Buffalo
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