clinical trial · NCT05317819
Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
Hepatocellular CarcinomaAdvanced Hepatocellular CarcinomaADI-PEG20Placebo
brief summary
Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC
started
Mar 14, 2022
primary completion
Sep 1, 2028
completion
Dec 1, 2028
last updated
Dec 18, 2025
detailed description
Safety will be evaluated by laboratory tests, vital sign measurements, physical examinations and subject medical history which will be performed to detect new abnormalities and any deterioration in pre-existing conditions.
Efficacy will be determined by overall survival, progression free survival, pharmacodynamics (peripheral blood arginine and citrulline levels) and immunogenicity (antibodies to ADI-PEG 20).
official title
A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol