[Translation] A multicenter, open-label, externally controlled, single-arm study to evaluate the efficacy, safety, and PK/PD of recombinant urate oxidase for injection in the prevention and treatment of acute hyperuricemia caused by tumor lysis syndrome in pediatric patients with malignant tumors
主要目的:评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中预防和治疗肿瘤溶解综合征所致急性高尿酸血症的有效性。
次要目的:1.评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中预防和治疗肿瘤溶解综合征所致急性高尿酸血症时的安全性;2.评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中预防和治疗肿瘤溶解综合征所致急性高尿酸血症时的远期肾功能改善;3.评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中多次给药的药代动力学/药效动力学特征(PK/PD);4.评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中的免疫原性;5.评估注射用重组尿酸氧化酶在儿科恶性肿瘤患者中肿瘤溶解综合征的发生率。
探索性目的:评估注射用重组尿酸氧化酶在不同年龄段的儿科恶性肿瘤患者亚组人群中的有效性和安全性。
[Translation] Primary objective: To evaluate the effectiveness of recombinant uricase for injection in preventing and treating acute hyperuricemia caused by tumor lysis syndrome in pediatric patients with malignant tumors.
Secondary objectives: 1. To evaluate the safety of recombinant uricase for injection in preventing and treating acute hyperuricemia caused by tumor lysis syndrome in pediatric patients with malignant tumors; 2. To evaluate the long-term improvement of renal function in preventing and treating acute hyperuricemia caused by tumor lysis syndrome in pediatric patients with malignant tumors; 3. To evaluate the pharmacokinetic/pharmacodynamic characteristics (PK/PD) of recombinant uricase for injection after multiple doses in pediatric patients with malignant tumors; 4. To evaluate the immunogenicity of recombinant uricase for injection in pediatric patients with malignant tumors; 5. To evaluate the incidence of tumor lysis syndrome in pediatric patients with malignant tumors.
Exploratory objective: To evaluate the effectiveness and safety of recombinant uricase for injection in subgroups of pediatric patients with malignant tumors of different age groups.