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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2022-07-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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