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NCT01287585 · ClinicalTrials.gov registry record · Phase 3
Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
A Phase 3 study, sponsored by Polaris Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 636
- Enrollment target
NCT01287585: Completed Phase 3 study, sponsored by Polaris Group.
NCT01287585 is a Phase 3 study that has completed, run by Polaris Group. The registered enrollment target is 636 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287585, a Phase 3 study, has completed, sponsored by Polaris Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 636 participants
- Enrollment target
Study Summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the hepatocellular carcinoma cells will starve and die.
Primary Outcome
Overall survival - until death or study closure.
Interventions
- DRUG Placebo
- OTHER Best Supportive Care
- DRUG ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01287585 record still lists
NCT01287585 is an interventional study that assigns participants to a tested intervention. The registered 636 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01287585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287585 about?
NCT01287585 is a clinical study titled "Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy". This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothes...
What is the current status of trial NCT01287585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 636 participants. The study started on 2011-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01287585?
The interventions under investigation include: Placebo (DRUG), Best Supportive Care (OTHER), ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol) (DRUG).
Who is sponsoring clinical trial NCT01287585?
This trial is sponsored by Polaris Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01287585's enrollment target sits among peer trials
636 579th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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