A prospective, open-label study to assess the efficacy of sovateltide in filariasis patients with lower limb lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with at least a 25% reduction in a diseased limb volume from baseline to Day 28.
研究概览
简要总结
This is a Prospective, open-label clinical study to assess the safety and efficacy of sovateltide in patients with filariasis-induced lower limb lymphedema. A total of 20 patients with Filariasisinduced lower limb lymphedema will be enrolled in this study
The enrolment period of the study will be approximately 3 months, and the total duration of the study will be approximately 6 months. For an individual patient, the duration of the study will be 28 days, including 2 study visits: visit 1 and visit 2. A total of 20 patients will be enrolled in the study after meeting the eligibility criteria
Treatment of enrolled subject: Sovateltide along with Standard of Care
All patients enrolled in this study will receive sovateltide in addition to the standard of care for lymphatic filariasis. Sovateltide will be administered at a dose of 0.3 mcg per kg as an IV bolus over 1 minute at every 3 hours of interval on days 1, 3, and 6. Each patient will be monitored closely throughout the study duration from randomization and will be assessed for efficacy and safety parameters over 28 days from randomization at a clinic visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female aged 18 to 80 years
- •Patient or his and her Legally Acceptable Representative willing to give informed consent before the study procedure.
- •Clinical diagnosis of lymphatic filariasis with WHO Stage 2 or 3 lower limb lymphedema
- •Ability to comply with study procedures.
排除标准
- •Pregnancy or breastfeeding
- •History of malignancy or significant immunological disorders
- •Recent limb surgery or trauma, or a candidate for any surgical intervention during the study duration.
- •Evidence of any other major life threatening or serious medical condition, such as severe renal, hepatic, and cardiovascular disease, which would prevent completion of the study protocol, impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient.
- •The patient is participating in another interventional study.
结局指标
主要结局
Number of patients with at least a 25% reduction in a diseased limb volume from baseline to Day 28.
时间窗: From baseline to Day 28.
次要结局
- Improvement in the Functional mobility assessment(questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at)
- Improvement in the Functional mobility assessment(questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at Day 28 compared to baseline)
- Proportion of patients with adverse events (AEs) and serious(adverse events (SAEs))
研究者
Dr. Manoj Kumar Pal
Janta Hospital and Maternity Center