N/A N=137 Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Cholangitis
Primary: Number of Participants With Cholangitis — 5; 5 participants — p=<0.05
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=24 Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Biliary Carcinoma · Gall Bladder Carcinoma · Cholangiocarcinoma
Primary: Progression Free Survival (PFS) — 6.2 months
Phase 3 N=34 Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Primary Sclerosing Cholangitis
Primary: Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 — 10; 6 Participants
Phase 2 N=68 A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Primary Biliary Cholangitis
Primary: Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline — 45.2; 46.4; 11.1…
Phase 2 N=13 N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
Biliary Atresia
Primary: Number of Patients With Biliary Atresia (BA) Achieving Total Serum Bile Acids Less Than or Equal to 10 *U*Mol/L Within 24 Weeks of Kasai Portoenterostomy (KP) — 0…
Phase 2 N=62 Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Pruritus
Primary: Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6 — -2.20; -1.75 scores on a scale — p=0.4577
Phase 2 N=119 Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
Primary: Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 — -26.06; -33.38; -41.42 percentage change from baseline — p== 0.2242
Phase 2 N=111 Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Primary Biliary Cirrhosis
Primary: The Percent Change in Serum GGT. — -4.9; -19; -8.4 percent change
N/A N=7 Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Biliary Stricture
Primary: Feasibility of Imaging the Bile Duct With the OFDI Probe — 7 Participants
Phase 2 N=121 Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Primary: Number of Participants With Treatment Emergent Adverse Events — 21; 10; 16; 15 Participants
Phase 2 N=76 A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Primary Biliary Cholangitis · Liver Stiffness
Primary: Change in ALP at Week 24 Compared to Baseline — 0.89; 0.84; 1.03 ratio — p=0.0206
Phase 2 N=8 Trial of IRE in Cholangiocarcinoma
Cholangiocarcinoma
Primary: Number of Patients Experiencing a Clinically Relevant Complications — 1; 7 Participants
Phase 2 N=77 Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC)
Primary: DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) — -105.05; -110.19; -26.76 U/L — p=0.0434
Phase 3 N=85 Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
Infantile Refsum's Disease · Zellweger Syndrome · Adrenoleukodystrophy
Primary: Number of Participants With Excretion of Atypical Bile Acids in Urine by Category — 10; 51; 11; 9 Participants
Phase 2 N=17 CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery
Adult Primary Cholangiocellular Carcinoma · Advanced Adult Primary Liver Cancer · Cholangiocarcinoma of the Extrahepatic Bile Duct
Primary: Overall Survival — 4.7; 1.6; 3.94 months
Phase 2 N=14 Study of Pembrolizumab and Olaparib in Bile Duct Cancer
Cholangiocarcinoma
Primary: Objective Response Rate (ORR) — 2 Participants
Phase 2 N=62 A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Primary: Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis — 25.6; -9.8; -0.6 International units/Liter — p=0.434
Phase 1 N=22 Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Cholestasis · Primary Sclerosing Cholangitis · Primary Biliary Cirrhosis
Primary: Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar — 100; 100 percentage of participants
Phase 1 N=35 A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Primary: Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment — -117; -49; -62; -36 U/L
N/A N=140 A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy
Biliary Atresia
Primary: The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy — 58.6; 48.6 percentage of participants — p=0.43
N/A N=119 Early Identification of Myocardial Impairment in PBC
Primary Biliary Cholangitis · Cardiovascular Abnormalities
Primary: The Incidence of Cardiac Events — 0; 0; 0; 0 Participants — p=0.001
Phase 3 N=53 Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis
Bile Acid Synthesis Defect
Primary: Change in Atypical Urinary Bile Acid Excretion by FAB-MS (Fast-Atom-Bombardment Ionization-Mass Spectrometry) — 25; 6; 10; 10 Participants
N/A N=19 FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
Cholecystitis
Primary: Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis — 9; 0; 1; 1 Participants
N/A N=72 Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).
Bile Duct Stricture · Choledocholithiasis
Primary: Number of Patients With Bacteremia — 25; 20; 5; 10 Participants
Phase 2 N=44 Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
Cancer of the Gallbladder · Cancer of the Biliary Tract
Primary: Number of Participants With Objective Response — 1 participants
N/A N=75 The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders
Disorders of the Pancreas and Biliary Tree
Primary: Successful Procedure Completion — 70; 5 participants
Phase 2 N=27 A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
Progressive Familial Intrahepatic Cholestasis · Alagille Syndrome · Cholestatic Liver Disease
Primary: Frequency of Treatment-emergent Adverse Events [TEAEs] — 16; 10; 4; 3 Participants
Phase 3 N=265 ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Primary Biliary Cholangitis
Primary: Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3…
Phase 2 N=30 Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Biliary Atresia
Primary: Feasibility of IVIG Treatment — 23 Participants
N/A N=677 Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Cholecystitis · Cholelithiasis
Primary: Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light — 64; 157; 159; 243 Participants