A Phase 2 interventional study of Diethylcarbamazine and Albendazole in Lymphatic Filariasis, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in Papua New Guinea. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by University Hospitals Cleveland Medical Center · Phase 2, Interventional, and Treatment
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 5th largest by enrollment, is one of 2 that started in 2014, is one of 5 in phase 2, and was the 7th 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 65 Years · all sexes · healthy volunteers too.
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 2014.
This study's enrollment of 182 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:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 5 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 will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.
This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.
There will be 3 treatment arms as follows:
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).
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
Drug: Diethylcarbamazine · Drug: Albendazole · Drug: Ivermectin
Diethylcarbamazine 6mg/kg
Also known as: DEC
Albendazole 400mg
Also known as: ALB, Albenda
Ivermectin 200 mcg/kg
Also known as: IVM, Stromectol
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
Time frame: at 36 months
Percentage of subjects with total clearance of Mf at 24 months.
Time frame: 24 months
Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months
Time frame: 24 months and 36 months
Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study
Time frame: 24 months and 36 months
Ran from May 2014 to primary completion in Dec 2017, 43 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Diethylcarbamazine · Albendazole
University Hospitals Cleveland Medical Center →