Trials / Completed
CompletedNCT00631579
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups. Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rasburicase (SR29142) |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2004-06-01
- Completion
- 2004-06-01
- First posted
- 2008-03-07
- Last updated
- 2009-10-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00631579. Inclusion in this directory is not an endorsement.