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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: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT01643408 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Interventions
- DRUG asparaginase Erwinia chrysanthemi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01643408 record still lists
NCT01643408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which asparaginase Erwinia chrysanthemi is the first listed.
NCT01643408 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01643408's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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