A Phase 2 interventional study of oxfendazole and albendazole in Helminthiasis, sponsored by Johns Hopkins Bloomberg School of Public Health. Withdrawn. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Treatment
The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).
This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.
Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.
37 studies on the registry are indexed under Helminthiasis; 2 are open to participants now.
Browse Helminthiasis studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients receive 6 mg/kg oxfendazole once
Drug: oxfendazole
patients receive 30 mg/kg oxfendazole once
Drug: oxfendazole
patients receive 6 mg/kg oxfendazole three times
Drug: oxfendazole
patients receive 400 mg albendazole once
Drug: albendazole
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
group receives one 400 mg dose of albendazole
Cure of Trichuris trichiura
Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.
Time frame: day 21 following treatment
Reduction in Trichuis trichiura eggs (compared to pretreatment)
Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.
Time frame: day 21 following treatment
Cure of other intestinal helminths
Absence of Ascaris, Necator eggs in stool using Kato Katz test
Time frame: day 21 following treatment
Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events
Cumulative adverse events following treatment up to Day 21
Time frame: treatment through day 21 following treatment
No study locations are listed for this record.
Plan to share: Yes — posting to CT.gov and publication
No publications or documents are linked to this record.
Start is estimated for Nov 2019; primary completion for Aug 2020, 9 months later.
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This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxfendazole
Johns Hopkins Bloomberg School of Public Health →