Hyperuricemia MedDRA version: 20.1 Level: LLT Classification code 10020907 Term: Hyperuricemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Fasturtec®
Product Name: Rasburicase
Product Code: SR29142
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RASBURICASE
CAS Number: 134774-45-1
Concentration unit: mg/ml mi
Sponsors
Sanofi-Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent. - Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent. - At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) = 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS = 30 on the Lansky score as per the Investigator’s preference. - Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy, baseline blood uric acid >8 mg/dL (473 µmol/L) at screening. - If newly diagnosed NHL patient with blood uric acid = 8 mg/dL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin’s lymphoma with high tumor burden which will be high risk of TLS (Tumor lysis syndrome). - If newly diagnosed AL patient is with blood uric acid = 8 mg/dL at the screening but with a high risk of TLS. - The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Acute promyelocytic leukemia - Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration. - Patients with abnormal liver or renal function. - Documented history of hereditary allergy or asthma. - Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia. - Patients with severe infection or active bleeding. - Previous therapy with urate oxidase. - Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug. - Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. - Pregnant or breastfeeding woman. - Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. - Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of rasburicase in pediatric patients with NHL and AL ;Secondary Objective: To assess efficacy of rasburicase for prevention and treatment of hyperuricemia;Primary end point(s): Incidence of AEs and SAEs : Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.;Timepoint(s) of evaluation of this end point: Day 1 to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Number of responders after completion of rasburicase treatment under chemotherapy: Response will be defined as achievement of normal uric acid levels (= 8.0 mg/dL) in those patients whose uric acid levels are >8.0 mg/dL 2)Proportion of patients who can maintain the normal uric acid levels throughout the study: In those patients whose baseline plasma uric acid levels are = 8 mg/dL but with a high risk of TLS 3)Percentage of the maximum decreasing degree of plasma uric acid level from baseline ;Timepoint(s) of evaluation of this end point: 1)2)3)Day 1 to Day 7 | — |
Countries
China
Contacts
Public Contactx
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Outcome results
None listed