NCT00002059已完成不适用
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
Newport Pharmaceuticals International2 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
The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:
- Comparison of total helper and suppressor T-cell number between the groups.
- Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
- Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Opportunistic infections or Kaposi's sarcoma.
- •Critical illness.
- •History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.
- •Concurrent Medication:
- •Steroids.
- •Cytotoxic immunosuppressive agents.
- •Concurrent Treatment:
- •Radiotherapy.
- •The following are excluded:
- •Opportunistic infections or Kaposi's sarcoma.
- •Critically ill patients.
- •Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.
- •Patients who have received any other immunotherapy.
- •Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.
- •Prior Medication:
- •Any other immunotherapy.
- •Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.
排除标准
- 未提供
研究者
研究点 (2)
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