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NCT01528384 · ClinicalTrials.gov registry record · Phase 1
Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient
A Phase 1 study, sponsored by Polaris Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01528384: Completed Phase 1 study, sponsored by Polaris Group.
NCT01528384 is a Phase 1 study that has completed, run by Polaris Group. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01528384, a Phase 1 study, has completed, sponsored by Polaris Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior treatments. The study hypothesis is that this drug will be safe in pediatric patients.
Primary Outcome
Change from baseline in laboratory values, as a measure of safety.
Interventions
- DRUG ADI-PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01528384 record still lists
NCT01528384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 is the first listed.
NCT01528384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01528384 about?
NCT01528384 is a clinical study titled "Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient". This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior treatments. The study hypothesis is that this drug will be safe in pediatric patients.
What is the current status of trial NCT01528384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01528384?
The interventions under investigation include: ADI-PEG 20 (DRUG).
Who is sponsoring clinical trial NCT01528384?
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 NCT01528384's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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