Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 8 participants
Start Date 2011-12
Est. Completion 2014-03
Phase Phase 1

Sponsor

Polaris Group

13 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.