A Phase 2 interventional study of DEC/Albendazole in Lymphatic Filariasis and Wuchereria Bancrofti Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in India. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, 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 3rd largest by planned enrollment, is one of 2 that started in 2006, is one of 5 in phase 2, and was the 2nd 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 · 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.
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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 |
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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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This study, conducted in Chennai, India, will determine whether a new treatment regimen of albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The infection can lead to swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment.
Healthy people between 18 and 55 years of age who are in good health and who are infected with Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the study. They are screened with a medical history, a brief physical examination, ultrasound (picture generated by sound waves) of the groin or chest, and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts.
Participants undergo the following procedures:
-4-day hospitalization
Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC given twice a year for 2 years)
Urine pregnancy test for women of childbearing age
Receive first treatment dose
Monitoring for symptoms
-6-month outpatient visit
Short history, physical examination and blood test
Second treatment dose for subjects receiving 800 mg albendazole
Urine pregnancy test for women of childbearing age
-1-year outpatient 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 worm
Urine pregnancy test for women of childbearing age
-18-month outpatient visit
Short history, physical examination and blood test
Fourth treatment dose for subjects receiving 800 mg albendazole
Urine pregnancy test for women of childbearing age
-24-month outpatient visit
Short history, physical examination and blood test
Final dose of albendazole and DEC at standard doses
Repeat ultrasound in subjects whose first ultrasound detected adult worms
Urine pregnancy test for women of childbearing age
Albendazole and diethylcarbamazine (DEC) are currently used in combination for annual mass treatment of lymphatic filariasis in all parts of the world except 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. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). 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 two years to determine whether the higher dose, more frequent regimen is more effective.
Age 18 years to 55 years inclusive.
Both genders.
Not pregnant or breastfeeding by history.
If selected, subject must be willing to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.
If selected, subject must be willing to undergo nighttime blood draws every 6 months for 2 years.
If selected, agree to have blood stored for future studies.
Ability to understand and sign the .
EXCLUSION CRITERIA (SCREENING):
Non-volunteers.
Age less than 18 years or greater than 55 years.
Pregnant or breastfeeding by history.
INCLUSION (TREATMENT):
Age 18 years to 55 years.
Men and non-pregnant or non-breastfeeding women.
Microfilarial levels greater than 50 mf/ml.
Willingness to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.
Willingness to undergo nighttime blood draws every 6 months for 2 years.
Ability to understand and sign the informed consent.
levels for inclusion greater than 9 g/dL.
Normal Cr, .
Willingness to have blood stored for future studies.
EXCLUSION (TREATMENT):
Non-volunteers.
Age less than 18 years or greater than 55 years.
Pregnancy or breast-feeding.
Hgb less than or equal to 9 g/dL.
Cr greater than 1.2/100 ml.
ALT greater than 30 U.
Alcohol consumption of more than 2 beers or other alcohol-containing drink/day within a week of each drug administration.
Temperature greater than 37.5 degrees C.
Serious medical illness.
History of benzimidazole allergy.
History of DEC allergy.
Use of albendazole or DEC within past 6 months.
Unwillingness to comply with required study visits.
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).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug page: Albendazole
Microfilarial levels.
Time frame: 12 months.
Adult worm burden.
Time frame: 12 and 24 months.
The record gives a start of Sep 2006, a primary completion of Apr 2011 and a completion of Apr 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 Apr 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albendazole
National Institute of Allergy and Infectious Diseases (NIAID) →