NCT00002024已完成不适用
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Topical acyclovir.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
- •Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
- •Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
- •Neutropenia unless it is pre-existing.
- •Thrombocytopenia unless it is pre-existing.
- •Concurrent Medication:
- •Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs.
- •Patients with the following are excluded:
- •Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
- •Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
- •Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
- •Neutropenia unless it is pre-existing.
- •Thrombocytopenia unless it is pre-existing.
- •Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.
研究者
研究点 (1)
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