The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Area Under the Curve (AUC)
Primary endpoints for AUC\_0-8, AUC\_0 last, AUC\_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.
Time frame: 28 days
Cmax
Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.
Time frame: 28 Days
Tmax & t1/2 Parameters
Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.
Time frame: 28 Days
Levels of CK18/M30
Caspase-cleaved cytokeratin serum levels (CK18/M30)
Time frame: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
Levels of CK18/M65
Caspase full-length cytokeratin serum levels CK18/M65
Time frame: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
Levels of Caspase 3/7 RLU
Concentration of Caspase 3/7 Relative Light Units
Time frame: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Scripps Clinic
La Jolla, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Sutter Pacific Medical Foundation
San Francisco, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Univerisity of Louisville Liver Research Center
Louisville, Kentucky, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Utah
Salt Lake City, Utah, United States
...and 16 more locations