HyperuricemiaPhase 4NCT00302653
Rasburicase in Tumor Lysis Syndrome
A Phase 4 study testing Rasburicase in people with Hyperuricemia, run by Sanofi at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Rasburicase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
List of inclusion Criteria:
- Acute hyperuricemia patients(uric acid>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.
List of exclusion Criteria:
- Hypersensitivity to uricases or any of the excipients.
- Known history of hemolytic anemia (G6PD deficiency).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- Rasburicase
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasburicaseDrug
Rasburicase 0,20mg/Kg/Day once a day 3-7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rasburicase 0,20mg/Kg/Day once a day 3-7 days Receives: Drug: Rasburicase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Measured: 24-48 hours after last dose of rasburicase
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Measured: 28 (+- 3) days after the last dose of rasburicase
Adverse events occurrence
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, Study director, Sanofi-aventis administrative office Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302653
- Sponsor's protocol ID
- L_9436
- Status last verified
- Sep 2009
- First submitted
- 10 Mar 2006
- Last updated
- 25 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
- ClinicalTrials.gov ID
- NCT00302653
- Acronym / sponsor ID
- L_9436
- Conditions
- Hyperuricemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Nov 2006 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RasburicaseRasburicase 0,20mg/Kg/Day once a day 3-7 days |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RasburicaseRasburicase 0,20mg/Kg/Day once a day 3-7 days | Drug | 1 |
Primary outcome
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Time frame: 24-48 hours after last dose of rasburicase
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
Time frame: 28 (+- 3) days after the last dose of rasburicase
Adverse events occurrence
Time frame: During the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaderson Lima study director
Sanofi-aventis administrative office Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasburicase in people with Hyperuricemia, run by Sanofi at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) (time frame: 24-48 hours after last dose of rasburicase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.