An interventional study of Albendazole 400mg and ivermectin 200mcg/kg and Albendazole and ivermectin in Lymphatic Filariasis, sponsored by London School of Hygiene and Tropical Medicine. Terminated at 1 site in Malawi. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-27.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Treatment
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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 7th largest by enrollment, is one of 2 that started in 2009, is one of 3 with no phase, and was the 4th 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: 18 Years to 55 Years · all sexes · healthy volunteers too.
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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 2009.
This study's enrollment of 70 is below 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.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
London School of Hygiene and Tropical Medicine 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 |
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Among the 10 studies testing albendazole in Elephantiasis, Filarial, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.
Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.
The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.
The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Annual treatment
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Annual treatment
Drug: Albendazole and ivermectin
albendazole 400mg and ivermectin 200mcg/kg given twice a year
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
Drug page: Albendazole
400 mg orally given annually
Drug pages: Albendazole · Ivermectin
albendazole 800 mg and ivermectin 400mg orally given annually
Drug page: Albendazole
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Drug page: Albendazole
albendazole 800mg and ivermectin 400mcg/kg given twice a year
Number of Participants Achieving Microfilarial Clearance
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
Time frame: 12 months
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample
Time frame: 24 months
| Milestone | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Albendazole 800mg and Ivermectin 400mcg/kg Annually | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually |
|---|---|---|---|---|
| Started | 18 | 17 | 18 | 17 |
| Completed | 15 | 13 | 13 | 13 |
| Not completed | 3 | 4 | 5 | 4 |
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
| participants | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Albendazole 800mg and Ivermectin 400mcg/kg Annually | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually |
|---|---|---|---|---|
| Number of Participants Achieving Microfilarial Clearance | 15 | 14 | 13 | 17 |
Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample
| participants | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Albendazole 800mg and Ivermectin 400mcg/kg Annually | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually |
|---|---|---|---|---|
| Number of Participants With Microfilarial Clearance at 24 Months of Follow up | 17 | 17 | 14 | 17 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albendazole 400mg and Ivermectin 200mcg/kg Annually | — | 0/18 (0%) | 5/18 (27.8%) |
| Albendazole 800mg and Ivermectin 400mcg/kg Annually | — | 0/17 (0%) | 7/17 (41.2%) |
| Albendazole 400mg and Ivermectin 200mcg/kg Biannually | — | 0/18 (0%) | 6/18 (33.3%) |
| Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually | — | 0/17 (0%) | 4/17 (23.5%) |
| Event | Albendazole 400mg and Ivermectin 200mcg/kg Annually | Albendazole 800mg and Ivermectin 400mcg/kg Annually | Albendazole 400mg and Ivermectin 200mcg/kg Biannually | Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually |
|---|---|---|---|---|
| FeverGeneral disorders | 2/18 | 4/17 | 3/18 | 1/17 |
| headacheGeneral disorders | 3/18 | 4/17 | 4/18 | 2/17 |
| joint painsGeneral disorders | 2/18 | 1/17 | 3/18 | 2/17 |
| abdominal painsGeneral disorders | 1/18 | 2/17 | 1/18 | 1/17 |
| Age, Continuous(years) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Median | 32.5 (21 to 50) | 31 (20 to 53) | 27.5 (18 to 55) | 35 (20 to 54) | 33 (18 to 55) |
| Sex: Female, Male(Participants) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Female | 3 | 6 | 7 | 7 | 23 |
| Male | 15 | 11 | 11 | 10 | 47 |
| Region of Enrollment(participants) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Malawi | 18 | 17 | 18 | 17 | 70 |
| Microfilarial count /uL(microfilaria/uL) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Geometric mean | 464.7 (250.1 to 863.4) | 338.7 (198.7 to 577.4) | 204.5 (204.5 to 287.8) | 264.7 (175.0 to 400.4) | 298.6 (207.3 to 389.4) |
| HIV status(participants) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Number | 0 | 0 | 0 | 0 | 0 |
| Eosinophil count(cells/uL) | Albendazole 400mg and Ivermectin 200mcg/kg Annual | Albendazole 800mg and Ivermectin 400mcg/kg Annual | Albendazole 400mg and Ivermectin 200mcg/kg Biannual | Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual | Total |
|---|---|---|---|---|---|
| Geometric mean | 1300 (1000 to 1700) | 1400 (1000 to 1900) | 1600 (1100 to 2100) | 1100 (900 to 1500) | 1300 (1000 to 1800) |
The record gives a start of Jan 2009, a primary completion of Feb 2012 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2015, 3 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Albendazole · Ivermectin
London School of Hygiene and Tropical Medicine →