Clinical trials: Biliary Cholestasis
Malignant Biliary Obstruction
Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage
Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology and Hepatology at the University Hospital of Leuven.
- Trial name
- PETRUS (NCT01686425)
- Testing
- Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Progressive Familial Intrahepatic Cholestasis (PFIC)
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX).
- Trial name
- INDIGO (NCT02057718)
- Testing
- LUM001 (Maralixibat)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
- Trial name
- NCT02148146
- Testing
- Omegaven
- Where
- 2 sites in United States
- Sponsor
- University of California, San Diego
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
Study of [14C]CS0159 in China Healthy Subjects
Study of [14C]CS0159 in China Healthy Subjects.
- Trial name
- NCT06098027
- Testing
- [14C]CS0159
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Primary Biliary Cirrhosis
Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia
Biliary atresia (BA) is the most frequent cause of chronic cholestasis in neonates, accounting for at least 50% of pediatric liver transplantation. BA incidence is estimated to range from 1:5000 to 1:19000 live births.
- Trial name
- UCMSCBA (NCT04522869)
- Testing
- Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation
- Where
- 2 sites in Vietnam
- Volunteers
- 20 people
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
Primary Biliary Cirrhosis
Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis
Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often require liver transplantation. The cause of disease is unknown.
- Trial name
- HAART (NCT01614405)
- Testing
- TDF/FTC/LPV/r
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- University of Alberta
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Gallstone Disease
Radiological Investigation of Bile Duct Obstruction
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed.
- Trial name
- RIBO (NCT02351492)
- Testing
- Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography, magnet resonance imaging
- Where
- Switzerland
- Volunteers
- 122 people
- Sponsor
- University Hospital, Basel, Switzerland
Ursodeoxycholic Acid, Primary Biliary Cirrhosis
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost…
- Trial name
- NCT03489889
- Testing
- Ursodeoxycholic Acid 300mg tablet, Ursodeoxycholic Acid 300mg capsule
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital
Alagille Syndrome
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS).
- Trial name
- ASSERT-EXT (NCT05035030)
- Testing
- Odevixibat
- Where
- 35 sites in United States, Belgium and 8 more
- Volunteers
- 62 people
- Sponsor
- Albireo, an Ipsen Company
Autoimmune Hepatitis, Primary Biliary Cirrhosis
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine.
- Trial name
- NCT04933292
- Testing
- Methylprednisolone and Mycophenolate mofetil, Methylprednisolone and azathioprine
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Xiaoli Fan
Pancreatic Neoplasms, Cholestasis
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubinemia secondary to bile…
- Trial name
- NCT02267707
- Testing
- nab-paclitaxel, Gemcitabine
- Where
- 6 sites in United States, Germany
- Volunteers
- 1 people
- Sponsor
- Celgene
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.
Liver Cirrhosis, Biliary
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
- Trial name
- NCT00570765
- Testing
- Obeticholic Acid (OCA)
- Where
- 21 sites in United States, Austria and 5 more
- Volunteers
- 60 people
- Sponsor
- Intercept Pharmaceuticals
PBC, Primary Biliary Cholangitis (PBC)
Epidemiology of PrImary Biliary Cholangitis in Spain
Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant.
- Trial name
- EPIC-PBC (NCT07821463)
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Fundacio Privada Mon Clinic Barcelona
Choledocholithiasis
"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis
The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated.
- Trial name
- NCT03658863
- Testing
- endoscopic ultrasound, intraoperative cholangiography, ERCP
- Where
- Lithuania
- Volunteers
- 106 people
- Sponsor
- Vilnius University
Cholestasis
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
- Trial name
- URSONEONAT (NCT00846963)
- Testing
- Ursodiol
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Ibrahim Mohamed
Pruritus
J-LINX: Japan LINerixibat eXtension Study
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and…
- Trial name
- NCT07860710
- Testing
- Linerixibat
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline