NCT00919451已完成2 期
A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- improvement in nerve function
研究概览
简要总结
Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy
Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
- •Aged 18-65
- •Weigh more than 30Kg
排除标准
- •Unwillingness to give informed consent
- •Patients with severe active infections such as tuberculosis
- •Pregnant or breastfeeding women (see Appendix II)
- •Those with renal failure, abnormal renal function, hypertensive
- •Patients taking thalidomide currently or within the last 3 months
- •Patients not willing to return for follow-up
- •Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- •HIV positive
研究组 & 干预措施
Ciclosporin
Experimental
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
干预措施: ciclosporin (Drug)
结局指标
主要结局
improvement in nerve function
时间窗: at 24 weeks and 32 weeks
次要结局
- incidence of adverse effects(throughout 32 weeks)
- Skin lesion inflammation improvement(up to 36 weeks)
- extra prednisolone needed to control reaction(up to 36 weeks)
- rate of improvement of reaction(up to 36 weeks)
- Time to next reactional episode(up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Ciclosporin in the Management of New Type 1 Reactions in LeprosyLeprosyNCT00919815London School of Hygiene and Tropical Medicine73
已完成
2 期
Ciclosporin in the Management of New Erythema Nodosum LeprosumLeprosyNCT00919542London School of Hygiene and Tropical Medicine12
已完成
2 期
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum LeprosumLeprosyNCT00919776London School of Hygiene and Tropical Medicine20
已完成
1 期
Cyclosporine in Combination With Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma Refractory to Carfilzomib and High Expression of PPIA Gene in Myeloma CellsMultiple Myeloma in RelapseMultiple Myeloma, RefractoryNCT04813653Tel-Aviv Sourasky Medical Center3
已完成
1 期
Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and RifampinDrug Interaction PotentiationNCT03801746Akebia Therapeutics40