Rasburicase as a Uricolytic Therapy for Hyperuricemia in... | NCT00631579

Studies
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

NCT00631579

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 2, 2009Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Hyperuricemia
Leukemia
Lymphoma

Interventions

Rasburicase (SR29142)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2009

Last Update Posted Date

Oct 2, 2009Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Rasburicase (SR29142)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters and anti-SR29142 antibodies

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient suffering from:

acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
lymphoma,Stage ≥ III without regard to uric acid level; or
lymphomas, Stage II with bulky disease; or
lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
K.K.	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19076979	Derived	Ishizawa K, Ogura M, Hamaguchi M, Hotta T, Ohnishi K, Sasaki T, Sakamaki H, Yokoyama H, Harigae H, Morishima Y. Safety and efficacy of rasburicase (SR29142) in a Japanese phase II study. Cancer Sci. 2009 Feb;100(2):357-62. doi: 10.1111/j.1349-7006.2008.01047.x.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
C469709	rasburicase
D014503	Urate Oxidase

ID	Term
D010088	Oxidoreductases
D004798	Enzymes
D045762	Enzymes and Coenzymes

ID	Term
D033461	Hyperuricemia
D007938	Leukemia
D008223	Lymphoma