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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=410 Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Decompensated Cirrhosis and Ascites
Primary: Time to Liver Transplantation or Death Through 1 Year After Randomization: Percentage of Participants With an Event — 33.5; 38.6 percentage of participants — p=0.17
Phase 2 N=160 Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Compensated Cirrhosis · Nonalcoholic Steatohepatitis
Primary: Change From Baseline in Enhanced Liver Fibrosis Score at Week 48 — -0.071; 0.125; -0.213; 0.263 score on a scale
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=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=50 The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis
Cirrhosis · Aerobic Exercises · Lifestyle Modification
Primary: Time-domain Heart Rate Variability (HRV) Parameters: SDNN and RMSSD and SDANN — 75.87; 55.13; -4.77; -14.91 milliseconds — p=0.64
N/A N=70 Velacur by Sonic Incytes for Portal Hypertension
Portal Hypertension · Chronic Advanced Liver Disease
Primary: Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)…
Phase 2 N=6 Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
Cirrhosis · Ascites Hepatic
Primary: Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites — 6; 4; 3; 0 Participants
Phase 4 N=10 Tolvaptan for Ascites in Cirrhotic Patients
Ascites · Cirrhosis
Primary: Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) — 0 participants
Phase 4 N=29 Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Ascites · Cirrhosis
Primary: Time to Recurrence of Ascites. — 10; 8 days — p=<0.05
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=19 Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
Liver Cirrhosis
Primary: Liver Stiffness by Transient Elastography (FibroScan) — 22.6; 23 kPa
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
Phase 3 N=268 Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Hepatitis C Virus Infection
Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 83.3; 94.3; 87.8 percentage of participants…
N/A N=412 FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
Liver Fibrosis · Cirrhosis · Chronic Hepatitis B
Primary: The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold…
Phase 4 N=50 Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Liver Disease
Primary: Number of Participants That Reached Targeted International Normalized Ratio (INR) Within ±0.1 After First Fresh Frozen Plasma (FFP) Transfusion Completed. — 7; 17…
Phase 2 N=50 Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
Hepatitis C · Cirrhosis · Portal Hypertension
Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 72.0; 0; 71.4 percentage of participants
N/A N=4 A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
Liver Cirrhosis
Primary: Area Under the Concentration Time Curve of Caffeine, Omeprazole and Metoprolol in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) — 20600; 1520; 287…
Phase 2 N=2 LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed
Hepatocellular Carcinoma
Primary: The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM
N/A N=343 Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
NASH - Nonalcoholic Steatohepatitis · Cirrhosis · Portal Hypertension
Primary: Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT) — 190…
Phase 2 N=46 An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
Compensated Cirrhosis and Portal Hypertension
Primary: Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) — 0.438 L/min
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=28 A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
Liver Cirrhosis
Primary: Area Under the Concentration Time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) — 94.5; 120.2; 704.6 hours*nanomole/liters (h*nmol/l)
N/A N=232 Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
Cirrhosis
Primary: Avoidable Readmission — 23; 12 Number of Avoidable Readmissions
Phase 3 N=40 A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
Cirrhosis
Primary: Body Weight — -1.14; -1.37 kg
Phase 3 N=102 Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
Hepatitis C, Chronic · Liver Cirrhosis
Primary: Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response) — 41; 40; 21 Participants
Phase 2 N=339 Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Chronic HCV Infection
Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 86.7; 88.9; 86.4; 87.0 percentage of participants
N/A N=1,494 Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
End Stage Liver Disease · Decompensated Cirrhosis of Liver
Primary: Quality of Life (QOL) — 7.02; 8.01 score on a scale
N/A N=2,600 Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study
Liver Failure, Acute on Chronic
Primary: 28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate — 74; 124; 74 Participants
Phase 2 N=35 BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Hepatitis C, Chronic
Primary: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) — 61.1; 52.9 Percentage of participants