Clinical trials: Biliary Stasis
Hepatitis, Alcoholic
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
- Trial name
- NCT02024295
- Testing
- Ademethionine, Polyene Phosphatidyl choline
- Where
- 2 sites in China
- Volunteers
- 118 people
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Primary Biliary Cholangitis
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
- Trial name
- ELSPIRE (NCT06383403)
- Testing
- Elafibranor
- Where
- 60 sites in United States, Czechia and 8 more
- Volunteers
- 92 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
- Trial name
- EPICS-IV (NCT07424677)
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Zydus Therapeutics Inc.
Intrahepatic Cholestasis of Pregnancy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Where
- 4 sites in United States
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
Pancreatic Diseases, Bile Duct Obstruction
SpyGlass™ Discover Percutaneous
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
- Conditions
- Pancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases
- Trial name
- NCT04580940
- Testing
- SpyGlass™ Discover Digital System
- Where
- 7 sites in United States, Belgium and 5 more
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states.
- Trial name
- NCT02200029
- Testing
- Ademetionine IV+tablet, Ademetionine tablet
- Where
- 12 sites in Russia
- Volunteers
- 75 people
- Sponsor
- Abbott
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)
The main aim of the study is to check if TAK-625 improves symptoms of Progressive Familial Intrahepatic Cholestasis (PFIC), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543187
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Takeda
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Primary Biliary Cholangitis
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
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
- NCT05450887
- Testing
- Obeticholic Acid Tablets（OCA）, UDCA
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
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 (PBC)
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose.
- Trial name
- NCT06798454
- Testing
- PVT201
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.