Health Condition 1: B740- Filariasis due to Wuchereria bancrofti
Conditions
Interventions
Intervention1: Oxfendazole: Stage I: Sentinel Safety Cohort
Design: Open-label safety cohort conducted at one of two study sites.
Participants: A total of 6 participants will be enrolled, divided int
Sponsors
M/s. Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Adults aged 18-60 years of all genders, with a confirmed diagnosis of LF, with or without symptoms. 2. Body weight greater than or equals to 40 kg 3. Filarial test strip positive which confirms the presence of circulating filarial antigen 4. Microfilaria positive by microscopy 5. Harbor at least one motile worm detected by USG. 6. Agree to practice at least one highly effective method of contraception up till three months after randomization: a. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation - oral, intravaginal, and transdermal Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, implantable. b. Intrauterine device c. Bilateral tubal occlusion d. Vasectomized partner e. Sexual abstinence
Exclusion criteria
Exclusion criteria: 1) Symptoms, physical signs, vital signs or biological/laboratory signs suggestive of past or present systemic disorders, including but not limited to, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders, drug / alcohol abuse and other abnormalities likely to interfere with the interpretation results of the test) or to significantly affect the study outcomes as judged by the investigator. 2) Abnormal hepatic enzymes level that are more than 1.5 times of the upper limit of normal values. 3) Renal impairment confirmed by serum creatinine levels exceeding the upper limit of normal values. 4) Clinical condition requiring chronic medication- diabetes, hypertension, chronic kidney disease, hypothyroidism, chronic respiratory disease, malignancy, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS). Any other clinical condition requiring long-term medication â?? on the discretion of the physician. 5) Currently participating in any other drug trial or having participated in a trial in a period less than five half-lives of the investigational product. 6) Any antifilarial drug intake in the previous one month. 7) Known HIV positive status. 8) Hemoglobin below 10mg/dL at baseline. 9) Epileptic seizures within the past 10 years. 10) Acute and/or febrile illness requiring therapy within 14 days prior to baseline. 11) Use of concomitant medication that are contraindicated with albendazole and/or known hypersensitivity to albendazole or any other ingredient in its formulation. 12) Unacceptably high tobacco, alcohol, or drug abuse a. History of greater than seven alcoholic drinks per week. b. History of other illicit drug use within the past three years. c. History of occasional tobacco use (less than one pack per week on average) is acceptable. Individuals will be counseled to abstain from the use of tobacco and other substances of abuse from screening through day 10. 13) Pregnant (by urine pregnancy test) or Breastfeeding women. 14) Anyone who is planning to relocate to another state within the next six months. 15) Participant with lymphatic filariasis who need surgical intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parasitological cure (No adult worm motility) at 6 months identified by USG.Timepoint: 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasitological cure (No adult worm motility) at 1 and 3 months identified by USG.Timepoint: 1 Month and 3 Months.;Reduction in Microfilaria load at 1, 3 and 6 months as compared to the baseline.Timepoint: 1 Month, 3 Months and 6 Months.;Circulating filarial antigen test positive at 1, 3 and 6 months as compared to the baseline.Timepoint: 1 Month, 3 Month and 6 Month.;The proportion of participants with adverse events and severe adverse events within 6 months of starting the intervention.Timepoint: 6 Months.;The proportion of participants with change of laboratory parameters and vital signs as compared to the baseline recorded as adverse event.Timepoint: Day 3 and Day 6.;Cmax: Maximum concentration achieved after dosing; tmax: time to reach maximum concentration, AUC 0-t: Area under the curve from time 0 to t by trapezoidal method, AUC0-inf: Area under the curve from time 0 extrapolated to infinity by trapezoidal method, t1/2: terminal elimination half-life, 100 multiplied ([Cmax - Cmin] / Cavg)) and accumulation ratio of oxfendazole and its metabolites at steady state.Timepoint: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Jerin Jose Cherian
Indian Council of Medical Research
Outcome results
None listed