A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Recruiting
Phase 2
Interventional Study
Trichuriasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 249 (estimated)
- Sponsor
- Asociacion Benefica Prisma · Other
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About This Trial
This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
2. Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
3. T. trichiura\* is demonstrated in a stool sample obtained within 14 days before randomization and enrollmen…
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