NCT01635777已完成2 期
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
AB Foundation1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
Miltefosine efficacy will be >85%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years or older
- •nodules and papules consistent with post kala-azar dermal leishmaniasis
- •parasitological confirmation of Leishmania infection
排除标准
- •platelet count <100x 109/l,
- •leukocyte count <2.5 x 109/l ,
- •hemoglobin < 8.0 g/100 ml ,
- •liver function tests >3 times upper limit of normal range,
- •bilirubin >2 times upper limit of normal range,
- •serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);
- •any non-compensated or uncontrolled condition,
- •lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
- •treatment with any anti-leishmanial drug within the previous 12 weeks.
研究组 & 干预措施
12 weeks
Experimental
miltefosine 12 weeks
干预措施: Miltefosine (Drug)
8 weeks
Experimental
miltefosine 8 weeks
干预措施: Miltefosine (Drug)
结局指标
主要结局
Cure rate
时间窗: 12 months after end of treatment
次要结局
- adverse events(during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)Treatment of Cutaneous Leishmaniasis in Brazil.NCT00600548Hospital Universitário Professor Edgard Santos180
Unknown
3 期
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in ColombiaCutaneous LeishmaniasisNCT00487253Centro Internacional de Entrenamiento e Investigaciones Médicas150
尚未招募
3 期
Comparison of the effect and toxicity between two options for the treatment of Mucosal Leishmaniasis: Miltefosin and Liposomal Anfotericin BRBR-5r93wnCentro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz
已完成
3 期
Miltefosine for Children With PKDLPost Kala Azar Dermal LeishmaniasisNCT02193022International Centre for Diarrhoeal Disease Research, Bangladesh80
已完成
2 期
Oral Miltefosine Plus Topical Paromomycin In American Cutaneous LeishmaniasisCutaneous Leishmaniasis, AmericanNCT03829917Fundacion Nacional de Dermatologia120