Clinical trials: Biliary Stasis
Primary Biliary Cirrhosis
Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT
This is an investigator-initiated, double-blind crossover study on the mechanism of OCA treatment of patients with PBC. Hypothesis and significance The investigators will test the hypothesis that OCA administration to patients…
- Trial name
- NCT03253276
- Testing
- Obeticholic acid
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- University of Aarhus
Malignant Bile Duct Obstruction
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered [1].
- Trial name
- SEMS (NCT04805450)
- Testing
- ES before fully covered SEMS placement, no ES before fully covered SEMS placement
- Where
- Italy
- Volunteers
- 1,075 people
- Sponsor
- Istituto Clinico Humanitas
Pulmonary Tuberculosis, Tuberculosis Diagnosis
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software Afinion CRP assay (Alere Afinion, USA), which detects a…
- Conditions
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIV
- Trial name
- TB TRIAGE+ (NCT04666311)
- Testing
- Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB, CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
- Where
- 2 sites in Lesotho, South Africa
- Volunteers
- 1,400 people
- Sponsor
- Klaus Reither
Total Parenteral Nutrition-induced Cholestasis
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT02534077
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Pediatrix
Primary Biliary Cholangitis (PBC), Long-term Outcomes
PBC Long-term Outcomes Study
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of…
- Conditions
- Primary Biliary Cholangitis (PBC), Long-term Outcomes, Prognosis, Multicenter Prospective Study
- Trial name
- NCT07149675
- Where
- China
- Volunteers
- 4,000 people
- Sponsor
- Beijing Friendship Hospital
Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes
Diet in Twin Pregnancy: the Wellness of Mother and Babies.
The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular: incidence of maternal obstetric complications: gestational diabetes gestational hypertension or preeclampsia…
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy
- Trial name
- FIT (NCT05773677)
- Testing
- Specific Diet
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Mirizzi Syndrome, Cholelithiasis
Treatment of Mirizzi Syndrome
Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the…
- Conditions
- Mirizzi Syndrome, Cholelithiasis, Acute Cholecystitis
- Trial name
- NCT04672902
- Testing
- Single-operator cholangioscopy guided electrohydraulic lithotripsy
- Where
- Mexico
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Tecnologico de Monterrey
Bile Duct Obstruction, Extrahepatic
Clinical Validation of an Immunocytochemistry Method Using MARS1
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured.
- Trial name
- MARS1 (NCT04759794)
- Testing
- Cytology staining
- Where
- 5 sites in South Korea
- Volunteers
- 55 people
- Sponsor
- Gangnam Severance Hospital
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
Acute Liver Failure, Mitochondrial Diseases
Longitudinal Study of Mitochondrial Hepatopathies
The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating…
- Conditions
- Acute Liver Failure, Mitochondrial Diseases, End Stage Liver Disease, Respiratory Chain Deficiencies, Mitochondrial
- Trial name
- MITOHEP (NCT01148550)
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Arbor Research Collaborative for Health
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
Hepatobiliary Diseases
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases.
- Trial name
- NCT01200082
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Biliary Atresia, Alagille Syndrome
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely…
- Conditions
- Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension
- Trial name
- FORCE (NCT02922751)
- Testing
- Liver Stiffness Measurement (LSM)
- Where
- 13 sites in United States, Canada
- Volunteers
- 552 people
- Sponsor
- Arbor Research Collaborative for Health
Liver Cirrhosis, Biliary
Physical Therapy for Liver Cirrhosis
Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of patients with liver cirrhosis.
- Trial name
- NCT04629456
- Testing
- neuromuscular electric stimulation, Exercises
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Cairo University
Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC)
Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
The purpose of the registry is to know the status of primary biliary colgantis, autoimmune hepatitis, primary sclerosing cholagitis and genetic cholestatic diseases in Spain.
- Conditions
- Hepatitis Autoimmune Disease, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Cholestatic Genetic Diseases
- Trial name
- ColHai (NCT06767605)
- Where
- Spain
- Volunteers
- 5,000 people
- Sponsor
- Asociación Española para el Estudio del Hígado
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
Common Bile Duct Stricture
Comparison Between Transpapillary and Suprapapillary Metal Stent
If surgical treatment is not possible in patients with malignant obstruction in the common bile duct, placing metal stents using endoscopy is a standardized treatment to resolve biliary obstruction.
- Trial name
- NCT04503291
- Testing
- Metal stent placement
- Where
- South Korea
- Volunteers
- 156 people
- Sponsor
- Bucheon St. Mary's Hospital
Hepatitis, Primary Biliary Cholangitis
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
- Conditions
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- Trial name
- NCT04618575
- Testing
- Ursodeoxycholic acid combined with total glucosides of paeony, Ursodeoxycholic acid only
- Where
- China
- Volunteers
- 137 people
- Sponsor
- West China Hospital
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD
Primary Biliary Cirrhosis
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis.
- Trial name
- NCT01603199
- Testing
- High protein high fiber diet
- Where
- Mexico
- Volunteers
- 36 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran