NCT00002073已完成不适用
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Ortho Pharmaceuticals2 个研究点 分布在 1 个国家开始时间: 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
- 试验地点
- 2
研究概览
简要总结
To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Maintenance dose of zidovudine (AZT) of at least 400 mg daily.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •History of any primary hematologic disease.
- •Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
- •AIDS-related dementia.
- •Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
- •Presence of concomitant iron deficiency.
- •Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
- •Acute opportunistic infection.
- •History of seizures.
- •Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.
- •Must not have previously participated in any other r-HuEPO clinical studies.
- •Prior Medication:
- •Excluded within 30 days of study entry:
- •Experimental drug or experimental device.
- •Cytotoxic chemotherapy.
- •Excluded within 2 months of study entry:
- •Androgen therapy.
- •Clinical diagnosis of AIDS and related anemia.
- •Clinical diagnosis of AIDS.
- •Clinically stable for 1 month preceding study entry.
- •Maintenance dose of zidovudine (AZT) of at least 400 mg daily.
- •Substance abuse.
研究者
研究点 (2)
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