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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 is a Phase 1 study that has completed, run by Polaris Group. The registered enrollment target is 8 participants.
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.
Interventions
- DRUG ADI-PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01528384
The ClinicalTrials.gov registry entry for NCT01528384 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 1 intervention - of which ADI-PEG 20 is the first listed.
NCT01528384 reports 0 study locations.
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.
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