A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of alcohol-related cirrhosis due to alcoholic hepatitis resulting in acute-on-chronic liver failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Change in CLIF-C ACLF score from baseline to Day 8
Time frame: Baseline to Day 8
Percentage of subjects who experience at least 1 markedly abnormal treatment-emergent AE or SAE
The percentage of subjects who experience at least 1 treatment-emergent AE or SAE that meets the Sponsor's markedly abnormal criteria
Time frame: To Day 28
Percentage of subjects who experience at least 1 treatment-emergent clinical laboratory test result or abnormal ECG that meets the Sponsor's markedly abnormal criteria
The percentage of subjects who experience at least 1 treatment-emergent clinical laboratory test result or abnormal ECG that meets the Sponsor's markedly abnormal criteria
Time frame: To Day 28
Percentage of subjects who discontinue study drug due to an AE
Time frame: To Day 28
Change in naturally log-transformed key biomarkers
Change in naturally log-transformed key biomarkers (TB, IL-8, high sensitivity CRP \[hs-CRP\], and urinary NGAL)
Time frame: Baseline to day 8
Survival at Day 28 after initiation of TAK-242 therapy versus placebo
Time frame: Baseline to Day 28
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