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NCT00628628 · ClinicalTrials.gov registry record · Phase 2
Rasburicase in Patients at Risk for Tumor Lysis Syndrome
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT00628628: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00628628 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00628628, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives: 1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days 2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities. 3. To determine the safety and immunogenicity of rasburicase. 4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Primary Outcome
Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.
Interventions
- DRUG As Needed Rasburicase
- DRUG Fixed Dose Rasburicase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00628628 record still lists
NCT00628628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which As Needed Rasburicase is the first listed.
NCT00628628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00628628 about?
NCT00628628 is a clinical study titled "Rasburicase in Patients at Risk for Tumor Lysis Syndrome". Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Second...
What is the current status of trial NCT00628628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2008-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00628628?
The interventions under investigation include: As Needed Rasburicase (DRUG), Fixed Dose Rasburicase (DRUG).
Who is sponsoring clinical trial NCT00628628?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00628628's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 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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