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

NCT03435718 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OXF2 v3.21
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trichuris Infection

Keywords

oxfendazole; albendazole; Trichuris trichiura

Outcome Measures

Primary Outcomes (2)

• cure d14

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

  Day 14 of follow up

• cure d7

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

  Day 7 of follow up

Secondary Outcomes (5)

• improvement d21

  Day 21 of follow up

• improvement d14

  Day 14 of follow up

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

  Day 7 of follow up

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

  Day 14 of follow up

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

  Day 21 of follow up

Study Arms (5)

OXF6

EXPERIMENTAL

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

Drug: Oxfendazole

OXF15

EXPERIMENTAL

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

Drug: Oxfendazole

OXF30

EXPERIMENTAL

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

Drug: Oxfendazole

OXF15x3

EXPERIMENTAL

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

Drug: Oxfendazole

ALB400

ACTIVE COMPARATOR

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

Drug: Albendazole

Interventions

Oxfendazole DRUG

oral suspension

OXF15; OXF15x3; OXF30; OXF6

Albendazole DRUG

tablet

ALB400

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 outpatient, more than 18 years and less than 65 years of age.
• Written or witnessed oral informed consent has been obtained.
• 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.
• Female patients of child bearing potential, who are using an established method of birth control (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

You may not qualify if:

• The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
• Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
• The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
• The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
• The patient has received an investigational 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.
• 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.
• The patient has a known history of renal dysfunction or plasma creatinine ≥ 1.5 times upper limit of normal for age or a known history of hepatic dysfunction or liver enzymes ≥ 1.5 times upper limit of normal.
• The patient is unwilling or unable to take part in this study.
• The patient has previously been enrolled in the study.

Sponsors & Collaborators

• Oxfendazole Development Group: lead
• Universidad Peruana Cayetano Heredia, Lima, Peru: collaborator

MeSH Terms

Conditions

Trichuriasis

Interventions

oxfendazole; Albendazole

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

Study Officials

• Héctor Hugo Garcia, MD PhD

  Oxfendazole Development Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ellen codd, MS

CONTACT

484 557 3831; ellen.codd@oxfendazoledevelopmentgroup.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each patient's treatment condition will be masked by a code assigned at randomization. The study pharmacist will know this assignment. A person other than the investigator will administer the drug as directed by the pharmacists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted as a field trial. Patients will be randomly assigned to one of five treatment groups: 6 mg/kg, 15 mg/kg or 30 mg/kg oxfendazole as a single dose; 15 mg/kg oxfendazole on three consecutive days; or 400 mg albendazole as a single dose (50 patients per group). The main objective of this study is to assess the efficacy (Cure Rate) of oral oxfendazole. Secondary objectives are to assess the Egg Reduction Rate for Trichuris in those subjects not cured of infection, to assess the efficacy (Cure Rate and Egg Reduction Rate) of oxfendazole against other common intestinal helminth infections, and to assess the safety and tolerability of oxfendazole treatment in adult patients.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-11