NCT00002042已完成不适用
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
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 r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.
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
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following are excluded:
- •History of any primary hematologic disease.
- •HIV disease related dementia.
- •Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
- •Presence of concomitant iron deficiency.
- •Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
- •Acute opportunistic infection.
- •History of seizures.
- •Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
- •Concurrent Medication:
- •Zidovudine (AZT) therapy during the double-blind phase of study.
- •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 HIV disease.
- •HIV disease related dementia.
- •Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
- •Presence of concomitant iron deficiency.
- •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.
- •Zidovudine (AZT) therapy and during the double-blind phase.
- •Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.
- •Clinical diagnosis of AIDS or ARC.
- •Clinically stable for 1 month preceding study entry.
- •Patients should preferably be transfusion dependent.
- •Substance abuse.
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT TherapyCytopeniasHIV InfectionsNCT00002072Ortho Pharmaceuticals
已完成
不适用
The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are AnemicCytopeniasHIV InfectionsNCT00002303Ortho Pharmaceuticals
已完成
不适用
The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZTCytopeniasHIV InfectionsNCT00002302Ortho Pharmaceuticals
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 TherapyCytopeniasHIV InfectionsNCT00002073Ortho Pharmaceuticals
已完成
2 期
A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in Patients With Acquired Immunodeficiency Syndrome (AIDS) Who Are Receiving Zidovudine (AZT) TherapyAcquired Immunodeficiency SyndromeAnemiaNCT00270283Johnson & Johnson Pharmaceutical Research & Development, L.L.C.102