Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
154 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-12-06
Study Completion Date
2022-06-01
Brief Summary
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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.
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Detailed Description
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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:
* Safety: To compare rates and types of severe adverse events (grade 3 or higher) that occur within 7 days following 1 day or 3 days of treatment with triple drug treatment ("IDA" = diethylcarbamazine (DEC) with ivermectin (IVM) and albendazole (ALB)) with the comparator regimen of 1 day of treatment with ivermectin and albendazole (IA) in persons with active Onchocerca volvulus infections after pretreatment with ivermectin alone.
* Efficacy: To compare the effect of three treatment regimens (1 day of IDA, 3 days of IDA, or IA) for killing or sterilizing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.
This is an open label, randomized clinical trial.
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:
* Safety: To compare rates and types of severe adverse events (grade 3 or higher) that occur within 7 days following 1 day or 3 days of treatment with triple drug treatment ("IDA" = diethylcarbamazine (DEC) with ivermectin (IVM) and albendazole (ALB)) with the comparator regimen of 1 day of treatment with ivermectin and albendazole (IA) in persons with active Onchocerca volvulus infections after pretreatment with ivermectin alone.
* Efficacy: To compare the effect of three treatment regimens (1 day of IDA, 3 days of IDA, or IA) for killing or sterilizing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.
This is an open label, randomized clinical trial.
Conditions
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Onchocerciasis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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:
1. IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
2. IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
3. IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
1. IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
2. IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
3. IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
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.
Study Groups
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IVM + ALB
Single dose of oral IVM (150 µg/kg) plus ALB (400 mg)
Group Type
ACTIVE_COMPARATOR
IVM w/ ALB
Intervention Type
DRUG
Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
IDA x 1 dose
Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Group Type
EXPERIMENTAL
Single dose of IDA
Intervention Type
DRUG
Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
IDA x 3 doses
Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Group Type
EXPERIMENTAL
Three daily doses of IDA
Intervention Type
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)
Interventions
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IVM w/ ALB
Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
Intervention Type
DRUG
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)
Intervention Type
DRUG
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)
Intervention Type
DRUG
Other Intervention Names
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IA
IVM/DEC/ALB (x1)
IVM/DEC/ALB (x3)
Eligibility Criteria
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Inclusion Criteria
* Men and women who were previously enrolled in the preceding Part I study (Protocol ID#201804116) and residing in the study area
* Must have at least palpable subcutaneous nodule (onchocercoma)
* Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)
* Must have at least palpable subcutaneous nodule (onchocercoma)
* Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)
Exclusion Criteria
* Pregnant and breastfeeding mothers within 1 month of giving birth
1. Any cataract of any type preventing clear visualization of fundus or imaging on Optical Coherence Tomography (OCT).
3. Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry .12
4. Retinal Detachment or Retinal Break
5. Acute ocular infection (i.e., Viral conjunctivitis, corneal ulcer, endophthalmitis)
6. Optic Atrophy with visual field defect reproducible on confrontation visual field testing..
7. Exam consistent with Herpes Simplex Virus eye infection
8. Homonymous hemianopsia, quadrantanopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual Field testing and confrontation visual field testing.
9. Acute Angle Closure Glaucoma
10. Gonioscopy grade 0 (slit) limiting ability to safely dilate patient
11. Severe Tremor, blepharospasm, or other voluntary or involuntary motor condition that prevents ability to examine patient with slit lamp, OCT, gonioscopy, IOP measurement, fundus photography, and Frequency doubling technology perimetry.
12. Cognitive impairment sufficient to prevent ability to understand and perform Visual Acuity Test with Tumbling E chart, confrontation visual field, slit lamp exam, or any other ocular exam component.
13. Optic nerve edema
14. Active retinopathy or retinitis not attributable to onchocercal disease
15. History of uveitis not associated with onchocercal disease
16. Any pre-existing chorioretinal scar or retinal degeneration and other significant retinal pathologies (foveomacular schisis, dystrophies, arterial macroaneurysms etc) involving the macula.
17. Severe ocular pain, that patient rates as 9 or 10 out of 10 pain.
18. Best corrected or pinhole visual acuity worse than 6/60 (20/200)
19. Age related macular degeneration (AMD)
* 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.
1. Any cataract of any type preventing clear visualization of fundus or imaging on Optical Coherence Tomography (OCT).
3. Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry .12
4. Retinal Detachment or Retinal Break
5. Acute ocular infection (i.e., Viral conjunctivitis, corneal ulcer, endophthalmitis)
6. Optic Atrophy with visual field defect reproducible on confrontation visual field testing..
7. Exam consistent with Herpes Simplex Virus eye infection
8. Homonymous hemianopsia, quadrantanopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual Field testing and confrontation visual field testing.
9. Acute Angle Closure Glaucoma
10. Gonioscopy grade 0 (slit) limiting ability to safely dilate patient
11. Severe Tremor, blepharospasm, or other voluntary or involuntary motor condition that prevents ability to examine patient with slit lamp, OCT, gonioscopy, IOP measurement, fundus photography, and Frequency doubling technology perimetry.
12. Cognitive impairment sufficient to prevent ability to understand and perform Visual Acuity Test with Tumbling E chart, confrontation visual field, slit lamp exam, or any other ocular exam component.
13. Optic nerve edema
14. Active retinopathy or retinitis not attributable to onchocercal disease
15. History of uveitis not associated with onchocercal disease
16. Any pre-existing chorioretinal scar or retinal degeneration and other significant retinal pathologies (foveomacular schisis, dystrophies, arterial macroaneurysms etc) involving the macula.
17. Severe ocular pain, that patient rates as 9 or 10 out of 10 pain.
18. Best corrected or pinhole visual acuity worse than 6/60 (20/200)
19. Age related macular degeneration (AMD)
* 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.
Minimum Eligible Age
16 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Case Western Reserve University
OTHER
Sponsor Role
collaborator
University of Health and Allied Sciences
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gary Weil, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Christopher King, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Nicholas Opoku, MB, CHB, MSC
Role: PRINCIPAL_INVESTIGATOR
University of Health and Allied Sciences, Hohoe, Ghana
Locations
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University of Health and Allied Sciences
Hohoe, , Ghana
Site Status
Countries
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Ghana
References
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Reference Type
BACKGROUND
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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201910085
Identifier Type: -
Identifier Source: org_study_id
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