Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma
← catalyst calendarNCT05317819 · readout ≤ 773 d
Sponsored by Polaris Group (industry) · PII — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
300estimated
Sites
11
Countries
Taiwan, Vietnam
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-03-14 | actual | When the study began enrolling |
| Primary completion | Sep 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hepatocellular Carcinoma
- Advanced Hepatocellular Carcinoma
Interventions
- Drug: ADI-PEG20 — also filed as pegargiminase
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFOverall Survival (OS)
measured Approximately 18 months
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