Phase 3 N=2 Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition-related Hepatitis
Primary: Disease Progression as Measured by Serum Levels of Hepatic Enzymes
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Phase 2 N=11 Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Total Parenteral Nutrition-induced Cholestasis
Primary: Number of Participants With Normalization of Direct Bilirubin — 11 participants
Phase 3 N=21 Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Cholestasis
Primary: Rate of Rise of Direct Bilirubin as a Function of Time — 1.033001353; 1.05457485; 1.025504411; 1.049318179 mg/dL/day
N/A N=136 Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
Parenteral Nutrition-Associated Liver Disease
Primary: The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. — 39; 45 participants who developed Cholestasis
Phase 3 N=91 Cholestasis Reversal: Efficacy of IV Fish Oil
Parenteral Nutrition Associated Liver Disease · Short Bowel Syndrome · Gastrointestinal Disease
Primary: Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. — 11.7; 6.4 Weeks — p==0.001
Phase 2 N=72 Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Parenteral Nutrition Associated Liver Disease PNALD · Cholestasis
Primary: Number of Patients With Progression to Small Bowel Transplantation. — 19 Participants
Phase 3 N=40 Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Parenteral Nutrition Associated Cholestasis
Primary: Number of Participants With Parenteral Nutrition Associated Cholestasis — 6; 6 Participants — p=0.94
Phase 4 N=48 Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition Associated Liver Disease
Primary: Number of Participants With Resolution of the Direct Hyperbilirubinemia — 29 Participants
Phase 3 N=184 N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
Acute Liver Failure · Hepatic Encephalopathy
Primary: Survival — 68; 76 Participants — p=0.19
Phase 3 N=48 Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Cholestasis of Parenteral Nutrition
Primary: Number of Participants With Cholestasis — 1; 3; 7 Participants — p=0.590
N/A N=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
N/A N=293 Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
Cholestasis · Cholestasis of Parenteral Nutrition
Primary: Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study — 38.02 Days
Phase 3 N=2 Omegaven as Alternative Parenteral Fat Nutrition
Cholestasis · Cholestasis of Parenteral Nutrition
Primary: Number of Participant With Decrease in Direct Bilirubin Level — 2; 0 Participants
Phase 3 N=100 Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Parenteral Nutrition
Primary: Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay — 21; 29 number of nosocomial infections
Phase 2 N=55 Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis
Primary: Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. — -1.6; -0.1 NAS score units
Phase 3 N=247 Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Liver Diseases
Primary: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and…
Phase 2 N=18 Treating Nonalcoholic Steatohepatitis With Pioglitazone
Hepatitis
Primary: Number of Patients With Improvement in Liver Histology — 12 participants
Phase 3 N=44 Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Cholestasis
Primary: Incidence of Neonatal Cholestasis — 1; 2 Participants
Phase 2 N=37 Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
Fatty Liver
Primary: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) — 8; 9 Participants
N/A N=5,824 Comparison of Outcomes Between Parenteral and Enteral Nutrition
Deglutition Disorders
Primary: Mortality Calculated From Outcome Section From DPC Database at 90 Days — 359; 287 Participants
Phase 2 N=53 Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6…
Phase 2 N=25 Anti-LPS Antibody Treatment for Pediatric NAFLD
Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: Percent Change in Alanine Aminotransferase (ALT) Level — 11.99; -7.99 percentage change
Phase 4 N=105 Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment
Nonalcoholic Steatohepatitis
Primary: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) — 7; 13; 24 Participants
Early Phase 1 N=9 Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease
Fatty Liver
Primary: Hepatic Fatty Acid Oxidation
Phase 2 N=205 Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Non-Alcoholic Fatty Liver Disease · Non-Alcoholic Fatty Liver · Non-Alcoholic Steatohepatitis
Primary: Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo — -6.8; -8.2 Percentage of liver fat
Phase 2 N=4 Study of IV VTS-270 for Infantile Liver Disease Associated With Niemann-Pick Disease, Type C
Niemann-Pick Disease, Type C
Primary: Efficacy of Adrabetadex (VTS-270) to Reduce Plasma Levels of a Conjugated Bile Acid, Known as 5α-cholanic Acid-3β, 5α, 6β-triol N-(Carboxymethyl)-Amide — 32.6; 87.9 ng/ml
N/A N=10 Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Cholestasis
Primary: Number of Participants With a Change in Conjugated/Direct Bilirubin — 4 Participants
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=99 A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
Non-Alcoholic Fatty Liver Disease (NAFLD)
Primary: Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 — 8.14; -40.01; -30.14; -40.13 percent change — p=0.0000
Phase 2 N=20 Pentoxifylline for Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Change in Serum Alkaline Phosphatase Levels. — -57.3 U/L — p=0.001