HyperuricemiaPhase 2GRAAL2NCT00664144
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
A Phase 2 study testing Rasburicase (SR29142) in people with Hyperuricemia, run by Sanofi at 4 sites in 4 countries.
Trial summary
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Rasburicase (SR29142)
- How many people
- 33 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2002to Jan 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients with histologically proven aggressive Non Hodgkin's Lymphoma
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.
The secondary objectives were to :
- evaluate the efficacy of rasburicase in terms of renal protection,
- evaluate the safety of rasburicase in the two cohorts of patients,
- correlate efficacy and safety results with antibodies generation/level.
- Conditions
- Hyperuricemia
- Being tested
- Rasburicase (SR29142)
- Medical subject headings
- Hyperuricemia
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.
responder rate (based on normalization of uric acid levels)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJul 2002
- Primary completionJan 2005
- Study completionJan 2005
Why it stopped: due to poor enrollment
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664144
- Sponsor's protocol ID
- EFC4983
- Other IDs
- L_8433
- Acronym
- GRAAL2
- Status last verified
- Mar 2012
- First submitted
- 18 Apr 2008
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease
- ClinicalTrials.gov ID
- NCT00664144
- Acronym / sponsor ID
- GRAAL2 / EFC4983
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to poor enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Apr 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.
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.
The secondary objectives were to :
- evaluate the efficacy of rasburicase in terms of renal protection,
- evaluate the safety of rasburicase in the two cohorts of patients,
- correlate efficacy and safety results with antibodies generation/level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| Rasburicase (SR29142) | Drug | – |
Primary outcome
responder rate (based on normalization of uric acid levels)
Results and safety
The study was stopped early (reason given: due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
ICD study director
Sanofi
4 sites in 4 countries: 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 Hyperuricemia, run by Sanofi at 4 sites in 4 countries.
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: stopped early, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Germany, Italy. 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 was stopped early (reason given: due to poor enrollment). 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?
responder rate (based on normalization of uric acid levels). 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 7 Mar 2012.