Clofazamine in the Long Term Treatment of Leprosy, Phase III
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.
详细描述
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
研究设计
- 研究类型
- Expanded Access
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
- •Known or suspected leprosy confirmed by skin biopsy and/or slit skin smears.
- •Multibacillary leprosy (lepromatous leprosy or borderline-lepromatous).
- •Paucibacillary leprosy (borderline, borderline tuberculoid, or indeterminate) if there is involvement of the cranial nerves or active acute neuritis.
- •Known or suspected ENL(erythema nodosum leprosum) (a specific immune reaction with painful skin nodules and fever)
- •Known or suspected dapsone-resistant leprosy or relapsed leprosy.
- •Intolerance of other antileprosy antibiotic (where clofazamine is substituted as apart of multidrug regimen)
排除标准
- •Uncomplicated paucibacillary leprosy which would otherwise be treated with dapsone and rifampin only.
- •Known prior intolerance of Clofazamine
- •Any minor (even with parental consent)
- •Any fertile woman who is pregnant a specific immune reaction with painful skin rash and fever)