N/A N=15 Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Hepatic Encephalopathy
Primary: Percentage of Slow Wave Sleep and REM Sleep — 56 percentage of total sleep time per 24h
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=15 A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Cirrhosis · Hepatic Encephalopathy
Primary: Part A: The Rate of AEs and Tolerability of HPN-100 — 11; 9; 7; 4 Subjects
Phase 2 N=18 VE303 for Treatment of Hepatic Encephalopathy (HE)
Cirrhosis · Hepatic Encephalopathy
Primary: Number of Participants Who Experienced Serious Adverse Events up to Week 6 — 2; 0 Participants
Phase 4 N=222 The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
Hepatic Encephalopathy · Cirrhosis
Primary: Number of Participants Reporting a First Breakthrough HE Episode — 28; 15 Participants — p=0.0359
Phase 2 N=231 Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Acute Episode of Overt Hepatic Encephalopathy · Hepatic Encephalopathy
Primary: Percentage of Participants in Each HE Stage — 11; 6; 30; 40 percentage of participants
Phase 3 N=299 A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Hepatic Encephalopathy
Primary: Time To The First Breakthrough Overt HE Episode — 13; 20; 4; 23 events — p=<0.0001
N/A N=50 A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
Hepatic Encephalopathy
Primary: Complete Reversal — 80 percentage of participants
Phase 3 N=322 Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Hepatic Encephalopathy
Primary: Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event — 78; 15; 158; 49 Participants
Phase 2 N=60 FMT in Cirrhosis and Hepatic Encephalopathy
Cirrhosis · Hepatic Encephalopathy
Primary: Serious Adverse Events Related to FMT — 0; 0; 0; 0 Participants
N/A N=17 The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
Cirrhosis · Ascites · Liver Diseases
Primary: Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits — 10 Participants
Phase 2 N=71 Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Overt Hepatic Encephalopathy
Primary: Time to Overt Hepatic Encephalopathy (OHE) Resolution Determined Using the Hepatic Encephalopathy Grading Instrument (HEGI), Defined as HEGI Score < 2 — 36.1; 21.1…
N/A N=42 Rifaximin in Minimal Hepatic Encephalopathy
Hepatic Encephalopathy
Primary: Driving Performance — 7.6; 5.5 raw number of driving errors
Phase 2 N=50 MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Hepatic Cirrhosis · Hepatic Encephalopathy (HE)
Primary: Ammonia Plasma Levels at Baseline and Day 5 — 70.4; 91.4; 92.6; 78.1 μmol/L
Phase 3 N=56 A Trial to Improve Quality of Life in People With Cirrhosis
Cirrhosis
Primary: Short Form-8 Health Survey (SF-8) at 28 Days — 8.1; 6.55; 70.9; 63.84 score on a scale — p=0.6
Phase 2 N=36 PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia
Hyperammonemia
Primary: Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs) — 6; 6; 7; 8 participants
N/A N=49 Probiotics for Liver Cirrhosis With Portal Hypertension
Liver Cirrhosis · Portal Hypertension
Primary: Admission Due to Complications Related to Portal Hypertension — 2; 3 participants — p=0.25
N/A N=22 Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Hepatitis C
Primary: Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and…
Phase 3 N=500 High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Phase 2 N=47 Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
Acute Liver Failure · Acute Liver Injury
Primary: Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability — 0; 0…
N/A N=45 Monitoring of Symptoms and Cognitive Function Using Telehealth
End Stage Liver Disease
Primary: Patient Satisfaction — 45 Participants
Phase 4 N=10 Ramelteon for Treatment of Insomnia in Cirrhosis
Cirrhosis
Primary: Sleep Quality Evaluation — 4.63; 11.75 score on a scale
N/A N=50 Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Hepatic Encephalopathy · Cirrhosis · Portosystemic Encephalopathy
Primary: Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours — 21; 13 participants
N/A N=28 Chronic Liver Disease in Urea Cycle Disorders
Urea Cycle Disorder
Primary: Liver Stiffness as Measured by Shear Wave Elastography — 13; 14 Participants
Phase 4 N=130 Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Alcoholic Liver Disease
Primary: Liver Enzymes(ALT) — 66; 48 IU/L
Phase 3 N=95 Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?
Adrenal Insufficiency · Cirrhosis · Spur Cell Anemia
Primary: Number of Participants With Cholesterol Esterification Deficiency — 10; 11 Participants
Phase 2 N=40 Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Hepatitis C Virus Infection
Primary: Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG — -0.03; -0.01; -0.03; -0.09 ratio…
N/A N=46 Neurologic Injuries in Adults With Urea Cycle Disorders
Brain Diseases, Metabolic, Inborn · Urea Cycle Disorder · Ornithine Transcarbamylase Deficiency
Primary: Concentration of Glutamine and Myoinositol by MRS — 4.97; 3.66; 3.78; 4.50 mM — p=0.003
Phase 1 N=9 Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine — 1137.36; 1177.94; 2213.26; 2768.25 mg*hr/L
Phase 3 N=91 Effects of SAMe in Patients With Alcoholic Liver Disease
Liver Disease, Alcoholic
Primary: Changes in Serum AST Levels — -13.5; -56 Units per liter (U/L)
N/A N=579 Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
Chronic Liver Disease
Primary: Hepatic Decompensation Event — 324 number of events