A Phase 1 interventional study of Ivermectin, Diethylcarbamazine Albendazole (IDA) in Wuchereria Bancrofti Infection, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in Côte D'Ivoire. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by University Hospitals Cleveland Medical Center · Phase 1, Interventional, and Other
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The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg + Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.
Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF) infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.
All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.
Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole (IDA) treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.
The study will be an open label cohort study with 2 two-treatment groups. Both groups will be treated with a single oral administration of DEC 6 mg/kg + ALB 400 mg + IVR 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72 hours and passive follow-up for 7 days following treatment.
Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 LF infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.
All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.
Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of IDA treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.
At enrollment all subjects will be otherwise healthy adult men and women (≥18-65 years of age). All individuals will be assessed for the presence and burden of geohelminth infections, parasitic worms of the gastrointestinal tract such as hookworm, Trichuris trichiuria and Ascaris lumbricoides. This is important because two of the drugs in the combination (ALB and IVM) are active against geohelminths. Individuals with heavy geohelminth burdens may experience adverse reactions because of rapid killing of their intestinal parasites.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 66 is below the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →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.
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Willingness to provide to participation in the study
Exclusion Criteria:
Known chronic illness, e.g. tuberculosis, diabetes, renal insufficiency
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).
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.
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.
Single oral dose of Ivermectin, Diethylcarbamazine Albendazole (IDA) W. bancrofti infections positive
Drug: Ivermectin, Diethylcarbamazine Albendazole (IDA)
Single oral dose of Ivermectin, Diethylcarbamazine Albendazole (IDA) in 40 individuals who are free of W. bancrofti infection.
Drug: Ivermectin, Diethylcarbamazine Albendazole (IDA)
To evaluate the safety and tolerability of triple drug therapy (a single dose of ALB, IVM and DEC)
Also known as: IDA
Drug Levels
Five mil-liters of blood will be taken to test drug levels
Time frame: up to 12 hours
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (aggregate)
Following drug administration, a review of subjective symptoms will be performed.
Time frame: up to 1 year
Impact of treatment on Hematuria and Proteinuria
Urine samples will be collected to examine the the presence and amount of blood and protein in the urine.
Time frame: up to 7 days
Number worm nests
In those individuals with LF, an ultrasound examination will be performed to identify the number of adult worm nests both before treatment and after.
Time frame: up to 1 year
Impact of treatment on Liver Function +
Blood samples will be collected to examine the impact of treatment on the levels of ALT, AST in the subjects blood.
Time frame: up to 7 days
Impact of treatment on Hemoglobin Levels
Blood samples will be collected to examine the impact of treatment on the levels of Hemoglobin in the subjects blood.
Time frame: up to 7 days
Impact of treatment on White Blood Cells
Blood samples will be collected to examine the impact of treatment on the levels of white blood count in subjects blood.
Time frame: up to 7 days
Plan to share: Yes
Ran from Apr 2016 to primary completion in Jun 2016, 2 months.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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