Onchocerciasis Clinical Trial
Official title:
A Randomized, Double Blind, Parallel Group Clinical Trial to Evaluate the Safety of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Treatment With Albendazole
Verified date | June 2024 |
Source | Medicines Development for Global Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.
Status | Active, not recruiting |
Enrollment | 12997 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of written informed consent, or assent with parental or guardian written consent* 2. Known O. volvulus skin microfilariae density =0 microfilariae/mg skin (participants =12 years of age only). 3. Living in an onchocerciasis endemic area. 4. Age =4 years 5. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). * Expression of 'deliberate objection' will be the basis for assessing assent of children aged = 4 to <6 years Exclusion Criteria: 1. Pregnant or breast-feeding. 2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health. 3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline. 4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients. 6. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations. 7. Infection with Loa loa. 8. Height <90 cm. |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Centre de Recherche pour les Maladies Tropicales Negligees | Rethy | Ituri |
Côte D'Ivoire | Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire | Abidjan |
Lead Sponsor | Collaborator |
---|---|
Medicines Development for Global Health |
Congo, The Democratic Republic of the, Côte D'Ivoire,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of treatment emergent adverse events | Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis. | Up to 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00300768 -
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
|
Phase 2 | |
Not yet recruiting |
NCT04035174 -
Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
|
N/A | |
Recruiting |
NCT03653975 -
Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District
|
||
Completed |
NCT03052998 -
Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy
|
Phase 4 | |
Active, not recruiting |
NCT03876262 -
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
|
Phase 3 | |
Terminated |
NCT04913610 -
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection
|
Phase 2 | |
Completed |
NCT03962062 -
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
|
Phase 1 | |
Completed |
NCT01905436 -
Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
|
||
Recruiting |
NCT00001230 -
Host Response to Infection and Treatment in Filarial Diseases
|
||
Completed |
NCT05750043 -
Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan
|
||
Completed |
NCT05749653 -
Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area
|
N/A | |
Completed |
NCT02078024 -
Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
|
Phase 3 | |
Completed |
NCT00127504 -
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
|
Phase 2 | |
Completed |
NCT03131401 -
Prevalence of LF Infection in Districts Not Included in LF Control Activities
|
||
Completed |
NCT02032043 -
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)
|
||
Completed |
NCT04188301 -
Safety and Efficacy of IDA for Onchocerciasis
|
Phase 2 | |
Terminated |
NCT05084560 -
Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug
|
Phase 1 | |
Completed |
NCT03517462 -
Ocular Changes After Ivermectin - (DOLF IVM/Oncho)
|
N/A | |
Active, not recruiting |
NCT05180461 -
Emodepside Phase II Trial for Treatment of Onchocerciasis
|
Phase 2 | |
Enrolling by invitation |
NCT06070116 -
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
|
Phase 2 |