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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 is a Phase 3 study that has completed, run by Polaris Group. The registered enrollment target is 636 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01287585
The ClinicalTrials.gov registry entry for NCT01287585 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Polaris Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01287585 reports 0 study locations.
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.
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