A Phase 2 interventional study of Albendazole and Diethylcarbamazine in Lymphatic Filariasis, 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 2015-08-31.
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 9th largest by enrollment, is the only one that started in 2007, is one of 5 in phase 2, and was the 3rd 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. 1 started in 2007.
This study's enrollment of 40 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:
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.
This tab as a report to print or save as PDF → With an account.
This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause 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 filarial worms may be eligible for this study.
Participants undergo the following procedures:
3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India
Monitoring for symptoms
6-month 3-day hospital stay
Urine pregnancy test for women of childbearing age.
1-year 3-day hospital stay
Urine pregnancy test for women of childbearing age.
18-month 3-day hospital stay
Urine pregnancy test for women of childbearing age.
24-month 3-day hospital stay
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, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be followed every 6 months for 2 years to determine whether the higher dose, and/or the more frequent regimen, is more effective.
Inclusion Criteria for Screening:
Inclusion Criteria for Treatment:
EXCLUSION CRITERIA:
Exclusion Criteria for Screening:
Exclusion Criteria for 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.
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.
Standard therapy of DEC (300mg) and albendazole (400mg) yearly
Drug: Albendazole · Drug: Diethylcarbamazine
High dose of DEC (300mg) and albendazole (800mg) yearly
Drug: Albendazole · Drug: Diethylcarbamazine
High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
Drug: Albendazole · Drug: Diethylcarbamazine
Comparing 400 mg to 800 mg dose
Also known as: Zentel
Providing diethylcarbamazine more frequently in combination with albendazole
Also known as: Banocide
Microfilarial Counts at 1 Year
Night time microfilarial counts at 1 year
Time frame: 1 year from time enrolled
Adult Worm Burdens at 2 Years
Doppler detected worm nests at 2 years
Time frame: 2 years from the time enrolled.
Microfilarial Levels at 2 Years
Night time microfilarial levels at 2 years
Time frame: 2 years from time enrolled
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
IgG4 antibodies directed against Brugia malayi antigen
Time frame: 2 years
Adults living in Kerala, India with Brugia malayi microfilaremia were recruited from field sites around the city of Alleppey and the study performed in the outpatient department of the TD Medical College.
| Milestone | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB |
|---|---|---|---|
| Started | 13 | 13 | 14 |
| Completed | 13 | 13 | 10 |
| Not completed | 0 | 0 | 4 |
| Withdrew: Lost to follow-up | 0 | 0 | 4 |
Night time microfilarial counts at 1 year
| MF/ML | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB |
|---|---|---|---|
| Microfilarial Counts at 1 Year | 0 (0 to 20) | 0 (0 to 12) | 0 (0 to 9) |
Doppler detected worm nests at 2 years
| Number of nests | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB |
|---|---|---|---|
| Adult Worm Burdens at 2 Years | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
Night time microfilarial levels at 2 years
| MF/ML | Diethylcarbamazine/Albendazole -STD | Diethylcarbamazine/Albendazole- HD1 | Diethylcarbamazine/Albendazole-HD2 |
|---|---|---|---|
| Microfilarial Levels at 2 Years | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
IgG4 antibodies directed against Brugia malayi antigen
| ng/ml | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB |
|---|---|---|---|
| Brugia Specific Immunoglobulin G4 (IgG4) Antibodies | 150 (0 to 1000) | 224 (0 to 2100) | 128 (0 to 650) |
Collected over Every 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Therapy Annual DEC/ALB | — | 0/13 (0%) | 9/13 (69.2%) |
| High Dose Annual DEC/ALB | — | 0/13 (0%) | 8/13 (61.5%) |
| High Dose Semiannual DEC/AC=LB | — | 0/14 (0%) | 11/14 (78.6%) |
| Event | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/AC=LB |
|---|---|---|---|
| MyalgiaMusculoskeletal and connective tissue disorders | 9/13 | 8/13 | 11/14 |
| FeverInvestigations | 5/13 | 4/13 | 4/14 |
| Nausea/VomitingGastrointestinal disorders | 1/13 | 1/13 | 0/14 |
| Age, Categorical(Participants) | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 13 | 14 | 40 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB | Total |
|---|---|---|---|---|
| Median | 36 (18 to 50) | 39 (18 to 50) | 37 (19 to 54) | 37 (18 to 54) |
| Sex: Female, Male(Participants) | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB | Total |
|---|---|---|---|---|
| Female | 9 | 10 | 10 | 29 |
| Male | 4 | 3 | 4 | 11 |
| Region of Enrollment(participants) | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB | Total |
|---|---|---|---|---|
| India | 13 | 13 | 14 | 40 |
| Blood microfilaremia (mf/ml)(MF/ML) | Standard Therapy Annual DEC/ALB | High Dose Annual DEC/ALB | High Dose Semiannual DEC/ALB | Total |
|---|---|---|---|---|
| Median | 412 (64 to 912) | 264 (112 to 1244) | 384 (108 to 748) | 384 (64 to 1244) |
The record gives a start of Jul 2007, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2015, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2015. 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) →