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NCT01643408 · ClinicalTrials.gov registry record · Phase 2

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT01643408 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 30 participants.

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The verdict

NCT01643408, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Interventions

  • DRUG asparaginase Erwinia chrysanthemi

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-11
Est. Completion 2013-12
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

What the Registry Record Tells You About NCT01643408

The ClinicalTrials.gov registry entry for NCT01643408 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which asparaginase Erwinia chrysanthemi is the first listed.

NCT01643408 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01643408 about?

NCT01643408 is a clinical study titled "A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy". This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the...

What is the current status of trial NCT01643408?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01643408?

The interventions under investigation include: asparaginase Erwinia chrysanthemi (DRUG).

Who is sponsoring clinical trial NCT01643408?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 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.