A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults

NCT04713787 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 18-0004HHSN272201300020IIND158335
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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. 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 study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method.

Conditions

Trichuriasis

Keywords

Adults; Albendazole; Comparative Study; Efficacy; Oxfendazole; Phase 2; Trichuris trichiura

Outcome Measures

Primary Outcomes (1)

• Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the Kato-Katz stool examination method

  As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).

  Day 18 through Day 23

Secondary Outcomes (12)

• Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the Kato Katz examination method

  Day 18 through Day 23

• Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the stool concentration examination method

  Day 18 through Day 23

• Change from baseline in eggs per gram of stool using the Kato-Katz stool examination method

  Day 18 through Day 23

• Change from baseline in eggs per gram of stool using the stool concentration method

  Day 18 through Day 23

• Egg reduction rate, relative to egg counts at baseline, measured using the Kato-Katz stool examination method

  Day 18 through Day 23

Study Arms (3)

Group A

EXPERIMENTAL

400 mg (4 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83.

Drug: Oxfendazole

Group B

EXPERIMENTAL

800 mg (8 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83.

Drug: Oxfendazole

Group C

ACTIVE COMPARATOR

400 mg (1 tablet of 400 mg) of Albendazole administered orally as a single dose on Day 1. N=83.

Drug: Albendazole

Interventions

Albendazole DRUG

Albendazole, 5-(prophylthio)-2-benzimidazole carbamate, is a broad-spectrum benzimidazole antihelminthic drug. It is provided as a white to off-white, circular, film-coated tablet with a slightly raised pentagonal projection on either side. This trial will use the 400 mg tablet formulation.

Group C

Oxfendazole DRUG

The active pharmaceutical ingredient is methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, which is a broad-spectrum benzimidazole antihelminthic. Oxfendazole is the sulphoxide metabolite of fenbendazole.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociacion Benefica Prisma: lead
• Policlinico Asociacion Benefica PRISMA-Laboratorio Satelite IQTLAB: collaborator
• National Institutes of Health (NIH): collaborator
• University of Iowa: collaborator
• University of Virginia: collaborator

Study Sites (1)

Policlinico Asociacion Benefica Prisma

Santa Clara de Nanay, Maynas, Peru

RECRUITING

MeSH Terms

Conditions

Trichuriasis

Interventions

Albendazole; oxfendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Patricia L. Winokur

CONTACT

13193844590; patricia-winokur@uiowa.edu

Margaret N Kosek

CONTACT

4439007269; mkosek@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is masked only to the laboratory personnel. All stool samples, labelled only with a barcode and the date of sample collection by the study team will be evaluated by blinded laboratory staff and will remain blinded until locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: September 7, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

PE (1)