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WithdrawnNCT03435718Updated Nov 6, 2026

Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults

A Phase 2 interventional study of Oxfendazole and Albendazole in Trichuris Infection, sponsored by Oxfendazole Development Group. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Oxfendazole Development Group · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study cancelled prior to initiation as the Oxfendazole Development Group is collaborating on a similar study being conducted by AB Prisma, NCT4713787
Updated Nov 6, 2026Now WithdrawnEnrollment updated+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.

Read the detailed description

This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.

02

Conditions studied

  • Trichuris Infection

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Keywords

  • oxfendazole
  • albendazole
  • Trichuris trichiura
03

In context

Trichuriasis

30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.

Browse Trichuriasis studies →

Lead sponsor

This is the only study on the registry with Oxfendazole Development Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female outpatient, more than 18 years and less than 65 years of age.
  2. Written or witnessed oral has been obtained.
  3. Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis or other helminths will not be a cause for exclusion.
  4. Willingness to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
  5. Female patients of child bearing potential, who are using an established method of (surgically sterile, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam) may be included

Exclusion criteria

Exclusion Criteria:

  1. The patient has demonstrated a previous reaction to benzimidazole or other related compound.
  2. Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
  3. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
  4. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
  5. The patient has received an drug within 30 days or 5 half-lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period.
  6. The patient has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication.
  7. The patient has a known history of renal dysfunction or plasma creatinine ≥ 1.5 times for age or a known history of hepatic dysfunction or liver enzymes ≥ 1.5 times upper limit of normal.
  8. The patient is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of (see inclusion criteria (4.2.5).
  9. The patient is unwilling or unable to take part in this study.
  10. The patient has previously been enrolled in the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    OXF6

    Patients receive a single 6 mg/kg dose of oxfendazole administered orally.

    Drug: Oxfendazole

  • Experimental
    OXF15

    Patients receive a single 15 mg/kg dose of oxfendazole administered orally.

    Drug: Oxfendazole

  • Experimental
    OXF30

    Patients receive a single 30 mg/kg dose of oxfendazole administered orally.

    Drug: Oxfendazole

  • Experimental
    OXF15x3

    Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.

    Drug: Oxfendazole

  • Active comparator
    ALB400

    Patients receive a single 400 mg/kg dose of albendazole administered orally.

    Drug: Albendazole

Interventions

06

What researchers measure

Primary outcomes

  1. cure d14

    absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

    Time frame: Day 14 of follow up

  2. cure d7

    absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

    Time frame: Day 7 of follow up

Secondary outcomes

  1. improvement d21

    reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

    Time frame: Day 21 of follow up

  2. improvement d14

    reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

    Time frame: Day 14 of follow up

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Day 7 of follow up

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Day 14 of follow up

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Day 21 of follow up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Withdrawn Study cancelled prior to initiation as the Oxfendazole Development Group is collaborating on a similar study being conducted by AB Prisma, NCT4713787
changed Nov 6, 2026
Enrollment
250 (estimated)→0 (actual)
Nov 6, 2026
Sponsor
Collaborators added: Universidad Peruana Cayetano Heredia; collaborators removed: Universidad Peruana Cayetano Heredia, Lima, Peru
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Not yet recruiting→Withdrawn
    Why stopped Study cancelled prior to initiation as the Oxfendazole Development Group is collaborating on a similar study being conducted by AB Prisma, NCT4713787
    Enrollment 250 (estimated)→0 (actual)
    Sponsor Collaborators added: Universidad Peruana Cayetano Heredia; collaborators removed: Universidad Peruana Cayetano Heredia, Lima, Peru
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03435718
Lead sponsor
Oxfendazole Development Group
Collaborators
Universidad Peruana Cayetano Heredia
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Jul 2024 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Nov 6, 2026

Study contacts

Héctor Hugo Garcia, MD PhD
principal investigator · Oxfendazole Development Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Oxfendazole

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