Phase 2 N=93 Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
Reperfusion Injury
Primary: Peak Aspartate Aminotransferase Within First 72h Post Transplant — 1262.9; 1451.2 U/L
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=38 A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
Nonalcoholic Steatohepatitis · Non-alcoholic Fatty Liver Disease
Primary: Change in Alanine Aminotransferase (ALT) — -37.8; -14.9 U/L — p=0.0195
Phase 1 N=20 Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults
Healthy
Primary: Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam — 22.0; 18.5; 9.92; 7.97 ng/mL
Phase 2 N=50 Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver Disease
Primary: Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF — 13.9; 8.4 percentage change in liver fat — p=0.585
N/A N=408 Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Lung Diseases, Interstitial
Primary: Incidence of Adverse Drug Reactions (ADRs) — 246 Participants
N/A N=125 Families-At-risk for Interstitial Lung Disease Study
Interstitial Lung Disease · Idiopathic Pulmonary Fibrosis
Primary: Number of Participants With ILA (Interstitial Lung Abnormalities) — 85; 13 Participants
Phase 4 N=30 Spironolactone After Liver Transplant
Transplant, Liver
Primary: Glomerular Filtration Rate (GFR) — 69; 64 ml/min/1.73m^2 — p=0.0001
Phase 1 N=36 PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
Hepatic Impairment · Liver Diseases · Digestive System Diseases
Primary: AUC — 113.5; 114.6; 423.7; 1042 h*ng/mL
Phase 1 N=2 Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
Hepatitis C · Liver Cirrhosis
Primary: AUC 0-∞ — 7240; 24700 h*ng/mL
Phase 3 N=1,206 Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
Hepatic Veno-Occlusive Disease
Primary: Survival by Day+100 Post Stem Cell Transplant or Chemotherapy — 49.9 Percentage of participants alive
Phase 2 N=64 Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Diabetes Mellitus, Type II · Fatty Liver
Primary: Insulin Resistance and Glucose Homeostasis — .69; .24; -0.51; .73 mg/kg/min — p=0.040
N/A N=3,800 Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
Cancer
Primary: Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) — 11 participants
Phase 3 N=203 Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
Acute Alcoholic Hepatitis
Primary: Overall Survival — 57; 66 Participants — p=0.904
Phase 2 N=64 A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
Liver Fibrosis · Hepatic Fibrosis · Liver Cirrhosis
Primary: Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score — 25; 14 participants — p=0.73
Phase 2 N=78 Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
Non-alcoholic Steatohepatitis
Primary: Efficacy - Improvement by at Least 2 Points in Histology (NAS) — 5; 4; 3 participants
N/A N=3,939 Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
Smoking Cessation
Primary: Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. — 377; 336 participants — p=<0.001
Phase 1 N=36 sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS
Autoimmune Hepatitis
Primary: Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements…
N/A N=451 Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Breast Neoplasms
Primary: Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane — 126; 324; 372; 68 participants
N/A N=11,157 Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Overactive Bladder
Primary: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). — 984 participants
Phase 2 N=60 Low Dose ICG for Biliary Tract and Tumor Imaging
Cholecystitis · Hepatocellular Carcinoma · Liver Metastases
Primary: Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio — 2.7; 0.7 ratio
Phase 3 N=80 Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
Reperfusion Injury · Liver Injury
Primary: Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels) — 83; 86.4 percentage change from baseline
Phase 2 N=12 The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NAFLD · Nonalcoholic Fatty Liver · NASH - Nonalcoholic Steatohepatitis
Primary: Intrahepatic Lipid Content (IHL, Percent Liver Fat) — 3.9 absolute change in percentage liver fat — p=0.4
Phase 2 N=18 Use of F-652 in Patients With Alcoholic Hepatitis
Alcoholic Hepatitis
Primary: The Number of Subjects With Unexpected Serious Adverse Events. — 0; 0; 0 Participants
Phase 2 N=400 LIPS-A: Lung Injury Prevention Study With Aspirin
Acute Respiratory Distress Syndrome
Primary: Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days — 20; 17 participants — p=0.53
Phase 2 N=80 Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver · Nonalcoholic Steatohepatitis
Primary: Absolute Change in Intrahepatic Lipid Content, by 1H-MRS — -6.6; 3.6 Mean absolute percentage change
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
Phase 4 N=15 deLIVER: Direct Acting Antiviral Effects on the Liver
HCV Coinfection · Liver Disease · HIV
Primary: Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy — 45; 16; 290; 2…
Phase 2 N=86 A Study of IDN-6556 in Subjects With Liver Cirrhosis
Liver Cirrhosis · Hepatic Cirrhosis
Primary: Change From Baseline at Month 3 in cCK18/M30 — 293.5; 257.5; 288.5; 285.0 U/L
N/A N=21 SRL (Sirolimus) Withdrawal
Acute Rejection of Liver Transplant · Effects of Immunosuppressant Therapy
Primary: Proportion of Tolerant Patients Off SRL Therapy With Normal Liver Biochemistry and Graft Histology at 12 Months — 8 Participants
N/A N=5,060 Drug-Targeted Alerts for Acute Kidney Injury
Acute Kidney Injury
Primary: Percentage of Patients With Progression of AKI OR Dialysis OR Death — 639; 585 Participants