HyperuricemiaPhase 3NCT00607152
Rasburicase (Fasturtec) Registration Trial
A Phase 3 study testing Rasburicase and Allopurinol in people with Hyperuricemia, run by Sanofi at 1 site in China.
Trial summary
Primary: To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma. Secondary: To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Rasburicase and Allopurinol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Jan 2009
- Phase
- Phase 3
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At high risk of malignancy and/or chemotherapy-induced hyperuricemia
- Performance status less than 3 on ECOG scale or more than 30% KPS scale
- Uric acid concentrations ≥ 8.0mg/dL
- Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia
Who cannot join
- Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
- Pregnancy or lactation
- Prior treatment with Uricozyme or Rasburicase
- Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
- Treatment with Allopurinol within the seven days preceding study Day 1
- History of significant atopic allergy problems or documented history of asthma
Show all 9Show fewer
- History of severe reaction to allopurinol
- Known history of glucose-6-phosphate dehydrogenase 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: A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
Primary:
To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.
Secondary:
To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).
- Conditions
- Hyperuricemia
- Being tested
- Rasburicase, Allopurinol
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasburicaseDrug
0.20mg/kg per day IV
AllopurinolDrug
100mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IV infusion at a dose level of 0.20mg/kg per day Receives: Drug: Rasburicase |
| 2 | Active comparator | 100mg tablets, administered orally, according to standard medical practice Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean plasma uric acid AUC0-96
Measured: 0hour, 4hour, 12 hour and q12h thereafter
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)
Measured: From administration of drug up to end of study
Biochemistry, hematology, vital signs, physical examination, and adverse events
Measured: From administration of drug up to end of study
Proportion of patients developing hypertension requiring therapy
Measured: From administration of drug up to end of study
Assays for circulating antibodies
Measured: From administration of drug up to end of study
Secondary outcomes (3)
Percentage reduction of plasma uric acid concentrations at T4h
Measured: From administration of drug up to end of study
Mean plasma uric acid concentrations
Measured: At various timepoints
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
Measured: From administration of drug up to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: the patient enrollment is too difficult
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Fu, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607152
- Sponsor's protocol ID
- RASBU_L_00351
- Status last verified
- May 2014
- First submitted
- 22 Jan 2008
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00607152
- Acronym / sponsor ID
- RASBU_L_00351
- Conditions
- Hyperuricemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the patient enrollment is too difficult
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Feb 2008 (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.
Primary:
To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.
Secondary:
To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RasburicaseIV infusion at a dose level of 0.20mg/kg per day |
| 2 | Active comparator | Drug: Allopurinol100mg tablets, administered orally, according to standard medical practice |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At high risk of malignancy and/or chemotherapy-induced hyperuricemia
- Performance status less than 3 on ECOG scale or more than 30% KPS scale
- Uric acid concentrations ≥ 8.0mg/dL
- Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia
Key exclusion criteria (9 listed)
- Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
- Pregnancy or lactation
- Prior treatment with Uricozyme or Rasburicase
- Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
- Treatment with Allopurinol within the seven days preceding study Day 1
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 |
|---|---|---|
| Rasburicase0.20mg/kg per day IV | Drug | 1 |
| Allopurinol100mg tablets | Drug | 2 |
Primary outcome
Mean plasma uric acid AUC0-96
Time frame: 0hour, 4hour, 12 hour and q12h thereafter
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)
Time frame: From administration of drug up to end of study
Biochemistry, hematology, vital signs, physical examination, and adverse events
Time frame: From administration of drug up to end of study
Proportion of patients developing hypertension requiring therapy
Time frame: From administration of drug up to end of study
Assays for circulating antibodies
Time frame: From administration of drug up to end of study
3 secondary outcomes
Percentage reduction of plasma uric acid concentrations at T4h
Time frame: From administration of drug up to end of study
Mean plasma uric acid concentrations
Time frame: At various timepoints
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
Time frame: From administration of drug up to end of study
Results and safety
The study was stopped early (reason given: the patient enrollment is too difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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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.
Jing Fu study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rasburicase and Allopurinol in people with Hyperuricemia, run by Sanofi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 8 May 2014. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: the patient enrollment is too difficult). Results are not available in the source record.
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?
Mean plasma uric acid AUC0-96 (time frame: 0hour, 4hour, 12 hour and q12h thereafter). The study lists 5 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 8 May 2014.