Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1751006 - ONCBL60801 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| World Health Organization | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidectin | Experimental | Moxidectin 8mg |
|
| Ivermectin | Active Comparator | Ivermectin 150 mcg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin | Drug | Single dose of moxidectin 2 mg oral tablet x 4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| skin microfilaria density (mf/mg) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| skin microfilaria density (mf/mg) | 1 month | |
| skin microfilaria density (mf/mg) | 6 months | |
| skin microfilaria density (mf/mg) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Special Programme for Research and Training in Tropical Diseases (TDR) | World Health Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche Clinique de Butembo - Université Catholique du Graben | Butembo | Democratic Republic of the Congo | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29361335 | Result | Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18. | |
| 35476631 |
| Label | URL |
|---|---|
| Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial | View source |
Not provided
| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| D015827 | Onchocerciasis, Ocular |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C027837 | moxidectin |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ivermectin |
| Drug |
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4 |
|
|
| 18 months |
| skin microfilaria reduction from baseline | 1 month |
| skin microfilaria reduction from baseline | 6 months |
| skin microfilaria reduction from baseline | 12 months |
| skin microfilaria reduction from baseline | 18 months |
| proportion of subjects with undetectable levels of skin microfilaria | 1 month |
| proportion of subjects with undetectable levels of skin microfilaria | 6 months |
| proportion of subjects with undetectable levels of skin microfilaria | 12 months |
| proportion of subjects with undetectable levels of skin microfilaria | 18 months |
| percent reduction in microfilaria levels in the anterior chamber of the eye | 12 months |
| Centre de Recherche en Maladies Tropicales de l'Ituri |
| Rethy |
| Democratic Republic of the Congo |
| Onchocerciasis Chemotherapy Research Center | Hohoe | Ghana |
| Liberian Institute for Biomedical Research Clinical Research Center | Bolahun | Lofa County | Liberia |
| Derived |
| Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 mug/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022 Apr 27;16(4):e0010079. doi: 10.1371/journal.pntd.0010079. eCollection 2022 Apr. |
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015822 | Eye Infections, Parasitic |
| D000079426 | Vector Borne Diseases |
| D015817 | Eye Infections |
| D005128 | Eye Diseases |