A Phase 2 interventional study of Albendazole and Ivermectin in Lymphatic Filariasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Mali. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 10 studies testing albendazole in Elephantiasis, Filarial — 1 open to participants now, 1 under way, none of them phase 3. Albendazole · Elephantiasis, Filarial.
Among the 10 studies testing albendazole in Elephantiasis, Filarial, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2006, is one of 5 in phase 2, and was the 1st registered.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
Browse Elephantiasis, Filarial studies →1 of the 10 studies testing albendazole in Elephantiasis, Filarial is open now, in 1 country. Recruiting first, the newest first:
Uwemedimo Friday Ekpo · Sites in Nigeria
Ages 5+ · Healthy volunteers
By country, each count listing its studies:
Albendazole: first FDA approval 1996 (ALBENZA). What it is approved for, and how studies give it, is on its page →
Of the 3 Elephantiasis, Filarial studies recruiting now, 2 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 14 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2006.
This study's planned enrollment of 1,000 is close to the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.
Median enrollment 164 across the 10 interventional studies. Of the 8 that completed or were terminated, 2 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 8 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
National Institute of Allergy and Infectious Diseases (NIAID) has 4 studies filed under Elephantiasis, Filarial — fewer than ten, so there is no comparison to draw.
1 of the studies testing albendazole in Elephantiasis, Filarial that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07707817Uwemedimo Friday EkpoExpanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations | 2027-07-30 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies testing albendazole in Elephantiasis, Filarial, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system.
Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts.
Participants undergo the following procedures:
-First visit
Ultrasound examination to look for filarial worms in the body.
Random assignment to receive either standard treatment or the experimental regimen
Urine pregnancy test for women of child-bearing age.
Receive first treatment dose.
-6-month visit
Short history, physical examination and blood test.
Second treatment dose for subjects in experimental treatment group.
Urine pregnancy test for women of childbearing age.
-1-year visit
Short history, physical examination and blood test.
Second or third treatment dose, depending on treatment group.
Repeat ultrasound in subjects whose first ultrasound detected adult worms.
Urine pregnancy test for women of childbearing age.
-18-month visit
Short history, physical examination and blood test.
Fourth treatment dose for subjects in experimental treatment group.
Urine pregnancy test for women of childbearing age.
-24-month visit
Short history, physical examination and blood test.
Repeat ultrasound in subjects whose first ultrasound detected adult worms.
Urine pregnancy test for women of childbearing age.
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programs is very high and has proven to be a major impediment to the success of programs in many countries with limited financial resources. Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose DEC/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. Furthermore, the optimal dose of ivermectin for the treatment of lymphatic filariasis is greater than that being used in the current mass treatment program. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + ivermectin 150 mcg/kg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + ivermectin 400 mcg/kg). If adequate numbers of microfilaremic subjects are recruited, an additional 25 volunteers will receive annual therapy with the increased dose combination. Microfilarial levels, as well as measures of adult worm burden (circulating antigen, ultrasound identification of adult worm nests) will be followed every six months for three years to assess the effects of the treatments.
men and women*.
EXCLUSION CRITERIA (Screening):
INCLUSION CRITERIA (Treatment):
EXCLUSION CRITERIA (Treatment):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wb microfilarial levels
Time frame: 12 months
Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound
Time frame: 12 months
The record gives a start of Feb 2006, a primary completion of Aug 2008 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Albendazole · Ivermectin
National Institute of Allergy and Infectious Diseases (NIAID) →