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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00628628
The ClinicalTrials.gov registry entry for NCT00628628 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which As Needed Rasburicase is the first listed.
NCT00628628 reports 0 study locations.
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.
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