Status:
RECRUITING
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Lead Sponsor:
Asociacion Benefica Prisma
Collaborating Sponsors:
Policlinico Asociacion Benefica PRISMA-Laboratorio Satelite IQTLAB
National Institutes of Health (NIH)
Conditions:
Trichuriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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. 24...
Detailed Description
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. 24...
Eligibility Criteria
Inclusion
- Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
- Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
- T. trichiura\* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.
- \*The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
- Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples\* over approximately 4- 6 weeks.
- \*An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.
- Females must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test 72 hours prior to the first study drug administration.\*ª
- \*If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -1) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative 72 hours prior to the first study drug administration.
- ª Pregnancy testing is not required for women of non-childbearing potential
- Female subjects of childbearing potential must be using effective contraception.\* \*Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged \>/=50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.
Exclusion
- Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).
- Has a diarrheal disease that would interfere with the evaluation of stool samples\*.
- \* More than 6 stools per day or stools that are completely liquid.
- Has received an antihelminthic within 14 days before enrolment.
- Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
- Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.
- Has a known history of renal dysfunction or plasma creatinine \>/=1.5 times the upper limit of normal (ULN) for age.
- Has a known history of hepatic dysfunction or AST, ALT, total bilirubin \>/=1.5 times the ULN.
- Has a hemoglobin that is less than 8 g/dL.
- Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose).
- Has previously been enrolled in this trial.
- Has any condition that would, in the investigator's opinion, interfere with this trial.
Key Trial Info
Start Date :
September 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT04713787
Start Date
September 7 2024
End Date
June 30 2026
Last Update
July 29 2025
Active Locations (1)
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1
Policlinico Asociacion Benefica Prisma
Santa Clara de Nanay, Maynas, Peru