A Phase 2 interventional study of Albendazole and Oxfendazole in Trichuriasis, sponsored by Asociacion Benefica Prisma. Recruiting at 1 site in Peru. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Asociacion Benefica Prisma · Phase 2, Interventional, and Treatment
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.
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. Water and a snack will be provided to aid in ingestion of the study product and a study team member will observe the ingestion of study product. 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. The secondary objectives are to: 1) assess the cure rate of different dose regimens of oxfendazole vs albendazole in the treatment of T. trichiura infections using the stool concentration examination method, 2) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the Kato-Katz stool examination method, 3) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the stool concentration method, 4) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the Kato-Katz stool examination method, 5) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the stool concentration examination method, 6) establish the spectrum of activity of oxfendazole against other intestinal helminths using the Kato-Katz stool examination method, 7) establish the spectrum of activity of oxfendazole against other intestinal helminths using the stool concentration examination method, 8) assess the tolerability of each oxfendazole dose group compared to the albendazole dose group, and 9) assess the safety in subjects treated with oxfendazole.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's planned enrollment of 249 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →This is the only study on the registry with Asociacion Benefica Prisma as lead sponsor.
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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.
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 , 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-
Exclusion Criteria:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400 mg (4 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83.
Drug: Oxfendazole
800 mg (8 capsules of 100 mg) of Oxfendazole administered orally as a single dose on Day 1. N=83.
Drug: Oxfendazole
400 mg (1 tablet of 400 mg) of Albendazole administered orally as a single dose on Day 1. N=83.
Drug: Albendazole
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.
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.
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).
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool for helminths other than Trichuris trichiura using the Kato Katz examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Time frame: 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
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool 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).
Time frame: Day 18 through Day 23
Change from baseline in eggs per gram of stool using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Time frame: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, measured using the Kato-Katz stool examination method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from egg counts (eggs per gram) from two stool samples (each evaluated in duplicate).
Time frame: Day 18 through Day 23
Egg reduction rate, relative to egg counts at baseline, using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from egg counts (eggs per gram) from two stool samples (each evaluated in duplicate).
Time frame: Day 18 through Day 23
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the stool concentration method
As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
Time frame: Day 18 through Day 23
Proportion of abnormal laboratory tests
As measured in each oxfendazole dose group compared to the albendazole dose group. Abnormal laboratory tests include hemoglobin (Hgb), white blood cells (WBC), neutrophil and eosinophil counts, platelet counts, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, and creatinine.
Time frame: Day 1 through Day 23
Proportion of solicited clinical reactogenicity events
As measured in each oxfendazole dose group compared to the albendazole dose group. Solicited clinical reactogenicity events including nausea, vomiting, abdominal pain, diarrhea, and anorexia.
Time frame: Day 1 through Day 23
Proportion of subjects in each dose group with moderate or heavy infection who had no infection or only light infection after treatment based on WHO classes of intensity, measured using the Kato-Katz tool examination method
According to WHO thresholds, infections of 1-999 eggs per gram (epg) are classified as light intensity infections, 1,000-9,999 epg are classified as moderate, and \>/= 10,000 epg are classified as heavy. Classification at baseline will be based on the screening stool sample, and classification post-treatment will be based on two stool samples each oxfendazole dose group compared to the albendazole dose group.
Time frame: Day 18 through Day 23
Proportion of unsolicited adverse events (AEs)
As measured in each oxfendazole dose group compared to the albendazole dose group.
Time frame: Day 1 through Day 23
Serious adverse events (SAEs) related to the study product
As measured in each oxfendazole dose group compared to the albendazole dose group.
Time frame: Day 1 through Day 23
Plan to share: Undecided
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Studies of the drug tested here: Oxfendazole