Clinical trials: Biliary Cholestasis
Biliary Atresia, Intrahepatic Cholestases
Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)
A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted.
- Conditions
- Biliary Atresia, Intrahepatic Cholestases, Normal Controls
- Trial name
- BA (NCT03890536)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Biliary Stones, Bile Duct Diseases
Flare Type Self-expandable Metal Stents (SEMS) vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone
Migration of stones from the gallbladder to the common bile duct (CBD) facilitated by gallbladder contractions can be listed as a complication of gallstones disease.
- Conditions
- Biliary Stones, Bile Duct Diseases, Bile Duct Obstruction
- Trial name
- TEMASTI (NCT06170632)
- Testing
- Biliary drainage
- Where
- Italy
- Volunteers
- 186 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
Primary Biliary Cirrhosis
Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA (13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free…
- Trial name
- NCT02916290
- Testing
- Fuzhenghuayu, UDCA
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Cholestasis, Congenital Heart Disease
Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years
Congenital heart diseases (CHDs) are common in infants with cholestasis due to shared prenatal and metabolic factors. This study aims to determine the frequency and types of CHDs and to assess physical and mental development in…
- Trial name
- NCT07247604
- Volunteers
- 106 people
- Sponsor
- Assiut University
Primary Biliary Cholangitis
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT05749822
- Testing
- Fenofibrate 200mg, UDCA
- Where
- 12 sites in China
- Volunteers
- 104 people
- Sponsor
- Xijing Hospital of Digestive Diseases
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
Primary Biliary Cholangitis
Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis
This phase I/II clinical trial evaluates human umbilical cord-derived mesenchymal stromal cell (hUC-MSC) injection in patients with primary biliary cholangitis (PBC).
- Trial name
- MSC-PBC-I/II (NCT07795151)
- Testing
- Standard background therapy, hUC-MSC Dose Level 1, hUC-MSC Dose Level 2
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Beijing 302 Hospital
Primary Biliary Cholangitis
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid…
- Trial name
- HEROES-PBC (NCT05293938)
- Testing
- Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA
- Where
- United States
- Sponsor
- Intercept Pharmaceuticals
Cholestasis
Omegaven® as Parenteral Nutrition
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo…
- Trial name
- NCT02334293
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Carle Foundation Hospital
Alagille Syndrome (ALGS)
A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
The main aim of the study is to check if TAK-625 improves symptoms of Alagille Syndrome (ALGS), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543174
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Takeda
Cholestatic Pruritus
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus.
- Trial name
- NCT03995212
- Testing
- CR845 1.0 mg
- Where
- 14 sites in United States
- Volunteers
- 14 people
- Sponsor
- Cara Therapeutics, Inc.
Bile Duct Obstruction, Extrahepatic
Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage
Prospective multi-site study of ultrasound-guided percutaneous biliary drainage and endoscopic ultrasound-guided biliary drainage with implantation of a self-expanding metal stent in patients with malignant, distal bile duct…
- Trial name
- PUMa (NCT03546049)
- Testing
- US-guided percutaneous biliary drainage, EUS-guided biliary drainage
- Where
- Germany
- Volunteers
- 216 people
- Sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Biliary Cirrhosis, Primary
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials.
- Trial name
- NCT02932449
- Where
- 39 sites in United States
- Volunteers
- 711 people
- Sponsor
- Target PharmaSolutions, Inc.
Primary Biliary Cholangitis
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.
- Trial name
- NCT07049887
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
The purpose of this study is to create a national, multi-centre registry for children with Alagille syndrome (ALGS) and Genetic Intrahepatic Cholestasis (GIC) that follows participants long-term, ensuring standardized…
- Conditions
- PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), Cholestasis, Intrahepatic
- Trial name
- PEARL (NCT07411716)
- Where
- 13 sites in Canada
- Volunteers
- 220 people
- Sponsor
- Children's Hospital of Eastern Ontario
Primary Biliary Cirrhosis, Autoimmune Hepatitis
Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis
The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.
- Trial name
- PBC (NCT00587119)
- Testing
- Budesonide
- Sponsor
- Mayo Clinic
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
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
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
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)