NCT00002015已完成不适用
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
Roche Global Development16 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 16
研究概览
简要总结
To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Topical acyclovir.
- •Consult with the Syntex study monitor for the following:
- •Cytokines.
- •Soluble CD
- •Trichosanthin (Compound Q).
- •Imipenem-cilastatin.
- •Other investigational drugs.
- •Patients must have the following:
- •Congenital or acquired immune deficiency.
- •Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
- •Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
- •Concurrent Medication:
- •Other myelosuppressive drugs.
- •Antimetabolites.
- •Alkylating agents.
- •Nucleoside analogs (topical acyclovir is allowed).
- •Interferons.
- •Foscarnet.
- •Consult with the Syntex study monitor for the following:
- •Cytokines.
- •Soluble CD
- •Trichosanthin (Compound Q).
- •Imipenem-cilastatin.
- •Other investigational drugs.
- •Patients with the following are excluded:
- •Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria.
- •Absolute neutrophil count (ANC) < 500 cells/mm3 or a platelet count < 25000 platelets/mm
- •Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding.
- •Receiving excluded medications that it is not possible to discontinue.
- •Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
- •Demonstrated hypersensitivity to acyclovir or ganciclovir.
研究者
研究点 (16)
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