Clinical trials: Biliary Stasis
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
Intrahepatic Cholestasis of Pregnancy, Arrhythmia
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave…
- Trial name
- NCT01906827
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Primary Biliary Cholangitis (PBC)
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment.
- Trial name
- NCT07296458
- Testing
- Fenofibrate, UDCA (Ursodeoxycholic acid)
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cholangitis (PBC)
Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)
The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80…
- Trial name
- NCT07205874
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Hospital Universitario La Paz
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.
Cholangitis, Secondary Biliary, Cholangiocarcinoma
Advanced Endoscopy During COVID-19
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.
- Conditions
- Cholangitis, Secondary Biliary, Cholangiocarcinoma, Obstructive Jaundice, Pancreas Cancer
- Trial name
- NCT04385147
- Testing
- Endoscopic management according to standard of care
- Where
- 5 sites in United States, Egypt and 3 more
- Volunteers
- 670 people
- Sponsor
- Al-Azhar University
Primary Biliary Cirrhosis
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT00364819
- Testing
- rituximab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
Biliary Stricture
A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival.
- Trial name
- NCT05826639
- Testing
- Temperature-sensitive radiofrequency ablation, No intervention
- Where
- United States
- Volunteers
- 176 people
- Sponsor
- Mayo Clinic
Liver Cirrhosis, Biliary
SAMe to Treat Biliary Cirrhosis Symptoms
This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver.
- Trial name
- NCT00125281
- Testing
- S-adenosyl-methionine (SAMe) capsules
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Biliary Cholangitis
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.
- Trial name
- NCT03322943
- Where
- China
- Volunteers
- 300 people
- Sponsor
- West China Hospital
Cholangiocarcinoma
Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP
This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs.
- Trial name
- PDT (NCT01439685)
- Where
- United States
- Sponsor
- Weill Medical College of Cornell University
Malignant Biliary Stricture
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these…
- Trial name
- NCT03530527
- Testing
- ERCP with biliary stenting, EUS guided biliary drainage
- Where
- 2 sites in Thailand
- Volunteers
- 10 people
- Sponsor
- Prince of Songkla University
Bile Duct Obstruction
Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain…
- Trial name
- FLUSH (NCT04915703)
- Testing
- Flushing of PTBD catheter
- Where
- Netherlands
- Volunteers
- 38 people
- Sponsor
- Erasmus Medical Center
Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
- Trial name
- NCT04047160
- Testing
- OP-724
- Where
- 2 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Kiminori Kimura, MD
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
- Trial name
- NCT06427395
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- 28 sites in United States, Argentina and 1 more
- Volunteers
- 102 people
- Sponsor
- Zydus Therapeutics Inc.
Cholestasis, Icterus
FGF19 in Obstructive Cholestasis: "Unveil the Signal"
Rationale: Bile salts are potent signalling molecules influencing various metabolic and functional processes. Bile salts exert these functions by activating nuclear (e.g. FXR ) and plasma cell membrane-bound receptors (e.g.
- Conditions
- Cholestasis, Icterus, Cholangiocarcinoma, Pancreatic Neoplasms
- Trial name
- FOCUS (NCT05718349)
- Testing
- Biospecimen sampling
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Nicole Hildebrand
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment.
- Trial name
- NCT07290257
- Testing
- Livmarli Oral Product
- Where
- 15 sites in Belgium, France and 6 more
- Volunteers
- 230 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis, Autoimmune, Primary Biliary Cholangitis
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
- Trial name
- NCT04617561
- Testing
- Ursodeoxycholic acid, Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- West China Hospital