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NCT04145531 · ClinicalTrials.gov registry record · Phase 2

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
229
Enrollment target

NCT04145531 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 229 participants.

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The verdict

NCT04145531, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
229 participants
Enrollment target

Study Summary

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Interventions

  • DRUG IM JZP-458
  • DRUG IV JZP-458

Trial Details

FieldValue
Enrollment Target 229 participants
Start Date 2019-12-27
Est. Completion 2022-07-13
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

What the Registry Record Tells You About NCT04145531

The ClinicalTrials.gov registry entry for NCT04145531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 229 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 2 interventions - of which IM JZP-458 is the first listed.

NCT04145531 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04145531 about?

NCT04145531 is a clinical study titled "An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)". This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in ...

What is the current status of trial NCT04145531?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2019-12-27. Estimated completion is 2022-07-13.

What interventions are being tested in trial NCT04145531?

The interventions under investigation include: IM JZP-458 (DRUG), IV JZP-458 (DRUG).

Who is sponsoring clinical trial NCT04145531?

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.