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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| University of Health and Allied Sciences | OTHER |
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This DOLF study will investigate the safety and effectiveness of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.
This study will provide preliminary data on the safety of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with IVM to clear or greatly reduce microfilariae from the skin and eyes. Widespread use of IDA following IVM pretreatment (I/IDA) has the potential to greatly accelerate elimination of lymphatic filariasis (LF) in African countries that are co-endemic for LF and onchocerciasis. study later.
This study will also assess the efficacy of IDA for killing and sterilizing adult filarial worms. An improved macrofilaricidal treatment would be a major advance for the global program to eliminate onchocerciasis. Since the safety and efficacy objectives are both very important, we have included dual primary objectives for the study.
Primary objectives:
This is an open label, randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVM + ALB | Active Comparator | Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) |
|
| IDA x 1 dose | Experimental | Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
|
| IDA x 3 doses | Experimental | Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVM w/ ALB | Drug | Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Severe Adverse Events (SAEs) Across Study Arms | Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB. | Within 7 days following end of treatment |
| Percentage of Worms Killed Across Study Arms | The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment. | 18 months following treatment. |
| Percentage of Worms Sterilized Across Study Arms | The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment. | 18 months following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | Rates of adverse events grade 3 or higher that occur within 7 days of treatment in the subset of participants who have intraocular microfilariae just prior to treatment with IDA will be compared by treatment group. | within 7 days following end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant and breastfeeding mothers within 1 month of giving birth
Severe eye disease at baseline including uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below. All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.
Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.
Prior allergic / hypersensitivity reactions or intolerance to IVM, ALB, or DEC.
Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.
>5 motile Mf in the anterior chamber in either eye at the time of enrollment (after pre-treatment with IVM).
Any Mf identified in the posterior segment of the eye at the time of enrollment (six months after pre-treatment with IVM).
Any other condition identified by study clinicians or investigators that may preclude participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Gary Weil, MD | Washington University School of Medicine | Principal Investigator |
| Christopher King, MD, PhD | Case Western Reserve University | Principal Investigator |
| Nicholas Opoku, MB, CHB, MSC | University of Health and Allied Sciences, Hohoe, Ghana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health and Allied Sciences | Hohoe | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28771480 | Background | Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available. | |
| 19154624 |
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Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
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Participants recruited in the Nkwanta North District in the Volta Region in Ghana through open community meetings.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVM + ALB | Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) IVM w/ ALB: Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) |
| FG001 | IDA x 1 Dose | Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Single dose of IDA: Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
| FG002 | IDA x 3 Doses | Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Three daily doses of IDA: Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Month 3 |
| |||||||||||||
| Month 12 |
| |||||||||||||
| Month 18 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVM + ALB | Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) IVM w/ ALB: Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) |
| BG001 | IDA x 1 Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rates of Severe Adverse Events (SAEs) Across Study Arms | Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB. | Posted | Count of Participants | Participants | Within 7 days following end of treatment |
|
Data was collected on adverse events for safety from baseline to 3 months after treatment. Serious adverse events and mortality were collected throughout the trial from baseline to 18 months after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVM + ALB | Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) IVM w/ ALB: Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
Pause on clinical trial operations between March 2020 - June 2020 due to the COVID-19 pandemic. Decreased health and viability of the adult female worm population in participants may have reduced the study's ability to detect a significant macrofilaricidal effect of IDA. Study enrolled participants with light/moderate infections, which greatly decreased the risk of SAEs occurring. Future studies to assess tolerability of IDA would need to be conducted with higher infection rates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Weil | Washington University in St. Louis | 3144547787 | gary.j.weil@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2020 | Apr 12, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Participants will be split into two strata - those without ocular Mf detected six months after ivermectin pretreatment in the Part I preceding study AND without ocular Mf detected at baseline in the part II study will be in stratum 1. Those participants with ocular Mf detected 6 months after ivermectin pretreatment in the preceding study OR with ocular Mf detected at the baseline exam for this study will be in stratum 2. Stratum 1 will be enrolled first, followed by stratum 2. Members of each stratum will be evenly randomized into one of three treatment arms:
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While this is an open label study and there is no placebo treatment group, all efforts will be made to ensure that that medical/technical staff assessing skin Mf, adverse events (AEs) and ophthalmological findings will be unaware of initial baseline skin and ocular Mf findings and treatment arm as best as possible.
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| Single dose of IDA | Drug | Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
|
|
| Three daily doses of IDA | Drug | Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
|
|
| Rates of Ocular Adverse Events (Any Grade) by Treatment Group | Rates of ocular adverse events of any grade within 3 months will be compared by treatment group. | within 3 months of treatment with IDA |
| Effectiveness of Killing Adult Female Worms | The effectiveness of three treatment regimens for killing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive 18 months after treatment. | 18 months following treatment |
| Effectiveness of Clearing Microfilariae From Skin by Skin Snips | The effectiveness of three treatment regimens for complete clearance of microfilariae from the skin as determined by skin snips at 3, 12, and 18 months after treatment with IDA will be compared by treatment arm. | Baseline, 3 months, 12 months, & 18 months following treatment. |
| Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips | The effectiveness of three treatment regimens for preventing reappearance of microfilariae in the skin as determined by skin snips at 12 and 18 months after treatment will be compared by treatment arm. Measured by the presence of microfilariae in skin snips. | Baseline, 12 months, and 18 months following treatment |
| Background |
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| 26161558 | Background | Rodriguez-Perez MA, Fernandez-Santos NA, Orozco-Algarra ME, Rodriguez-Atanacio JA, Dominguez-Vazquez A, Rodriguez-Morales KB, Real-Najarro O, Prado-Velasco FG, Cupp EW, Richards FO Jr, Hassan HK, Gonzalez-Roldan JF, Kuri-Morales PA, Unnasch TR. Elimination of Onchocerciasis from Mexico. PLoS Negl Trop Dis. 2015 Jul 10;9(7):e0003922. doi: 10.1371/journal.pntd.0003922. eCollection 2015. |
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| 28056015 | Background | Fischer PU, King CL, Jacobson JA, Weil GJ. Potential Value of Triple Drug Therapy with Ivermectin, Diethylcarbamazine, and Albendazole (IDA) to Accelerate Elimination of Lymphatic Filariasis and Onchocerciasis in Africa. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005163. doi: 10.1371/journal.pntd.0005163. eCollection 2017 Jan. No abstract available. |
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| 3521559 | Background | Taylor HR, Murphy RP, Newland HS, White AT, D'Anna SA, Keyvan-Larijani E, Aziz MA, Cupp EW, Greene BM. Treatment of onchocerciasis. The ocular effects of ivermectin and diethylcarbamazine. Arch Ophthalmol. 1986 Jun;104(6):863-70. doi: 10.1001/archopht.1986.01050180097039. |
| 24968000 | Background | Awadzi K, Opoku NO, Attah SK, Lazdins-Helds J, Kuesel AC. A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. PLoS Negl Trop Dis. 2014 Jun 26;8(6):e2953. doi: 10.1371/journal.pntd.0002953. eCollection 2014 Jun. |
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| 2658637 | Background | Taylor HR, Semba RD, Newland HS, Keyvan-Larijani E, White A, Dukuly Z, Greene BM. Ivermectin treatment of patients with severe ocular onchocerciasis. Am J Trop Med Hyg. 1989 May;40(5):494-500. doi: 10.4269/ajtmh.1989.40.494. |
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| 1457260 | Background | Awadzi K, Gilles HM. Diethylcarbamazine in the treatment of patients with onchocerciasis. Br J Clin Pharmacol. 1992 Oct;34(4):281-8. doi: 10.1111/j.1365-2125.1992.tb05632.x. No abstract available. |
| 29361335 | Background | 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. |
| 1268156 | Background | Bird AC, Anderson J, Fuglsang H. Morphology of posterior segment lesions of the eye in patients with onchocerciasis. Br J Ophthalmol. 1976 Jan;60(1):2-20. doi: 10.1136/bjo.60.1.2. |
| 678496 | Background | Fuglsang H, Anderson J. Further observations on the relationship between ocular onchocerciasis and the head nodule, and on the possible benefit of nodulectomy. Br J Ophthalmol. 1978 Jul;62(7):445-9. doi: 10.1136/bjo.62.7.445. |
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| 15363940 | Background | Jolodar A, Fischer P, Buttner DW, Miller DJ, Schmetz C, Brattig NW. Onchocerca volvulus: expression and immunolocalization of a nematode cathepsin D-like lysosomal aspartic protease. Exp Parasitol. 2004 Jul-Aug;107(3-4):145-56. doi: 10.1016/j.exppara.2004.06.006. |
| 7246523 | Background | Donner A, Koval JJ. A multivariate analysis of family data. Am J Epidemiol. 1981 Jul;114(1):149-54. doi: 10.1093/oxfordjournals.aje.a113162. |
| 26174515 | Background | Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015 Jun;44(3):1051-67. doi: 10.1093/ije/dyv113. Epub 2015 Jul 13. |
| 37205721 | Derived | Opoku NO, Doe F, Dubben B, Fetcho N, Fischer K, Fischer PU, Gordor S, Goss CW, Gyasi ME, Hoerauf A, Hong AR, Kanza E, King CL, Laryea R, Lew D, Seidu MA, Weil GJ. A randomized, open-label study of the tolerability and efficacy of one or three daily doses of ivermectin plus diethylcarbamazine and albendazole (IDA) versus one dose of ivermectin plus albendazole (IA) for treatment of onchocerciasis. PLoS Negl Trop Dis. 2023 May 19;17(5):e0011365. doi: 10.1371/journal.pntd.0011365. eCollection 2023 May. |
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Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Single dose of IDA: Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
| BG002 | IDA x 3 Doses | Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Three daily doses of IDA: Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Microfilarae positive | Presence of microfilariae in the anterior or posterior chamber of the eye at baseline | Count of Participants | Participants |
|
| OG002 | IDA x 3 Doses | Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Three daily doses of IDA: Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) |
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| Primary | Percentage of Worms Killed Across Study Arms | The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment. | The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. | Posted | Count of Units | Female worms in nodules | 18 months following treatment. | Female worms in nodules | Female worms in nodules |
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| Secondary | Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA | Rates of adverse events grade 3 or higher that occur within 7 days of treatment in the subset of participants who have intraocular microfilariae just prior to treatment with IDA will be compared by treatment group. | For the Arm IDA x 3 doses, no participants had intraocular microfilariae present at baseline. | Posted | Count of Participants | Participants | within 7 days following end of treatment |
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| Secondary | Rates of Ocular Adverse Events (Any Grade) by Treatment Group | Rates of ocular adverse events of any grade within 3 months will be compared by treatment group. | Posted | Count of Participants | Participants | within 3 months of treatment with IDA |
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| Secondary | Effectiveness of Killing Adult Female Worms | The effectiveness of three treatment regimens for killing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive 18 months after treatment. | Analysis conducted on participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. | Posted | Count of Units | Female worms in nodule | 18 months following treatment | Female worms in nodule | Female worms in nodule |
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| Secondary | Effectiveness of Clearing Microfilariae From Skin by Skin Snips | The effectiveness of three treatment regimens for complete clearance of microfilariae from the skin as determined by skin snips at 3, 12, and 18 months after treatment with IDA will be compared by treatment arm. | Posted | Geometric Mean | 95% Confidence Interval | Count of Skin Microfilaria | Baseline, 3 months, 12 months, & 18 months following treatment. |
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| Secondary | Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips | The effectiveness of three treatment regimens for preventing reappearance of microfilariae in the skin as determined by skin snips at 12 and 18 months after treatment will be compared by treatment arm. Measured by the presence of microfilariae in skin snips. | Posted | Number | Count of microfilarae+ participants | Baseline, 12 months, and 18 months following treatment |
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| Primary | Percentage of Worms Sterilized Across Study Arms | The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment. | The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. Female worms were excluded who had collapsed uteri that could not be evaluated for fertility. | Posted | Count of Units | Female worms with intact uterus | 18 months following treatment. | Female worms with intact uterus | Female worms with intact uterus |
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| 1 |
| 52 |
| 0 |
| 52 |
| 11 |
| 52 |
| EG001 | IDA x 1 Dose | Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Single dose of IDA: Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) | 1 | 51 | 0 | 51 | 15 | 51 |
| EG002 | IDA x 3 Doses | Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Three daily doses of IDA: Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) | 0 | 51 | 0 | 51 | 11 | 51 |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Itching skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Joint or muscle pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Itching, ocular | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Waist Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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Not provided
Not provided
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Male |
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| Negative for ocular microfilarae |
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| IA vs IDA3 for living female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.107 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.45 | 2-Sided | 95 | 0.92 | 2.29 | Superiority |
| Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.068 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.44 | 2-Sided | 95 | 0.97 | 2.15 | Superiority | IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment. |
| IDA vs IDA3 for living female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.918 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.03 | 2-Sided | 95 | 0.59 | 1.79 | Superiority |
| IA vs IDA3 for living female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.107 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.45 | 2-Sided | 95 | 0.92 | 2.29 | Superiority |
| IA vs IDA groups for living female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.068 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.44 | 2-Sided | 95 | 0.97 | 2.15 | Superiority |
| IDA vs IDA3 for living female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.918 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.03 | 2-Sided | 95 | 0.59 | 1.79 | Superiority |
| Month 3 |
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| Month 12 |
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| Month 18 |
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| Title | Measurements |
|---|---|
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| Month 18 |
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| IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.023 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 2.23 | 2-Sided | 95 | 1.12 | 4.44 | Superiority |
| IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.430 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.32 | 2-Sided | 95 | .64 | 2.85 | Superiority |
| IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment. | Regression, Logistic | Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person. | 0.023 | Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person. | Odds Ratio (OR) | 1.91 | 2-Sided | 95 | 1.09 | 3.34 | Superiority |