Health Condition 1: B948- Sequelae of other specified infectious and parasitic diseases
Conditions
Interventions
Intervention1: Sovateltide: Sovateltide will be administered at a dose of 0.3
mcg per kg as an IV bolus over 1 minute at every 3 hours on days 1, 3, and 6. Total dose per day: 0.9 mcg per kg.
Control
Sponsors
Janta Hospital and Maternity Center,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female aged 18 to 80 years 2. Patient or his and her Legally Acceptable Representative willing to give informed consent before the study procedure. 3. Clinical diagnosis of lymphatic filariasis with WHO Stage 2 or 3 lower limb lymphedema 4. Ability to comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. History of malignancy or significant immunological disorders 3. Recent limb surgery or trauma, or a candidate for any surgical intervention during the study duration. 4. 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. 5. The patient is participating in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with at least a 25% reduction in a diseased limb volume from baseline to Day 28.Timepoint: From baseline to Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the Functional mobility assessment questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at Day 28 compared to baselineTimepoint: From baseline to Day 28;Improvement in the Functional mobility assessment questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at Day 28 compared to baselineTimepoint: From baseline to Day 28.;Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)Timepoint: From baseline to Day 28 | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Pal
Janta Hospital and Maternity Center
Outcome results
None listed