Trials / Active Not Recruiting
Active Not RecruitingNCT06070116
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.
Detailed description
The open label, randomized clinical trial studies the safety and efficacy of combination regimens for the treatment of onchocerciasis. Around 300 participants from Bong Mines, Liberia will be randomly assigned to one of four treatment groups after receiving Ivermectin pre-treatment: Ivermectin plus Albendazole (IA0, Ivermectin plus DEC plus Albendazole (IDA), Moxidectin plus albendazole (MoxA), or Moxidectin plus DEC plus Albendazole (MoxDA). Participants will be treated at baseline and 6 months after initial treatment. Safety will be measured through extensive adverse event monitoring from baseline to 6 months. Efficacy of the treatment will be measured at 24 months after the initial treatment by the proportion of all adult female worms that are fertile in the Onchocerca nodules and the percentage of participants without microfilaremia at 6, 18, and 24 months after the first treatment.
Conditions
- Onchocercal Subcutaneous Nodule
- Onchocerciasis
- Onchocerciasis, Ocular
- Onchocerca Infection
- Tropical Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ivermectin w/ Albendazole | Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg) |
| DRUG | Ivermectin + Diethylcarbamazine + Albendazole | Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg) |
| DRUG | Moxidectin + Albendazole | Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg) |
| DRUG | Moxidectin + Diethylcarbamazine + Albendazole | Participants will be given a dose of oral Moxidectin (Mox) (8 mg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg) |
Timeline
- Start date
- 2024-04-05
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2023-10-06
- Last updated
- 2025-12-18
Locations
1 site across 1 country: Liberia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06070116. Inclusion in this directory is not an endorsement.