Nutritional and Metabolic DiseasesPhase 2NCT00290992
Rasburicase for Hyperuricemia
A Phase 2 study testing rasburicase (SR29142) in people with Nutritional and Metabolic Diseases, run by Sanofi at 1 site in Japan.
Trial summary
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- rasburicase (SR29142)
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2005to Apr 2006
- Phase
- Phase 2
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <18 years of age
- Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:
- Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old
- Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:
- Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
- Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:
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- At least one lymph node or mass >5 cm in diameter
- LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification
- Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc.
Who cannot join
- Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period.
- Low birth weight infant (<2500g) or gestational age <37 weeks
- Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period.
- Known history of severe allergic reaction and/or severe asthma.
- Known history or family history of glucose-6-phosphate dehydrogenase deficiency.
- Known history of hemolysis and methemoglobinemia.
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- Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN
- Uncontrollable infections (including viral infections).
- Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.
Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- rasburicase (SR29142)
- Keywords
- urate oxidase, hyperuricemia, lymphoma, leukemia
- Medical subject headings
- Nutritional and Metabolic Diseases, Hyperuricemia, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rasburicase (SR29142)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.
Secondary outcomes (4)
Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
G6PD activity will be measured in only patients who demonstrate hemolysis.
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
PK parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keiji OHNO, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290992
- Sponsor's protocol ID
- ACT5080
- Status last verified
- Mar 2009
- First submitted
- 10 Feb 2006
- Last updated
- 30 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome
- ClinicalTrials.gov ID
- NCT00290992
- Acronym / sponsor ID
- ACT5080
- Conditions
- Nutritional and Metabolic Diseases
- Keywords
- urate oxidase, hyperuricemia, lymphoma, leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 13 Feb 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.
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.
Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- <18 years of age
- Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:
- Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old
- Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:
- Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
Key exclusion criteria (9 listed)
- Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period.
- Low birth weight infant (<2500g) or gestational age <37 weeks
- Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period.
- Known history of severe allergic reaction and/or severe asthma.
- Known history or family history of glucose-6-phosphate dehydrogenase deficiency.
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 |
|---|---|---|
| rasburicase (SR29142) | Drug | – |
Primary outcome
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.
4 secondary outcomes
Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
G6PD activity will be measured in only patients who demonstrate hemolysis.
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
PK parameters.
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 30 Mar 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.
Keiji OHNO 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 2 study testing rasburicase (SR29142) in people with Nutritional and Metabolic Diseases, run by Sanofi at 1 site in Japan.
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 9 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: finished, as of the sponsor's last update on 30 Mar 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.. 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 30 Mar 2009.