One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
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ClinicalTrials.gov Identifier: NCT06367361 |
Recruitment Status :
Not yet recruiting
First Posted : April 16, 2024
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Fascioliasis | Drug: Oxfendazole Drug: Triclabendazole | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 336 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Study arm 1: Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation. Study arm 2: Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation. Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation. |
Masking: | Double (Care Provider, Outcomes Assessor) |
Masking Description: | The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint. |
Primary Purpose: | Treatment |
Official Title: | Non-inferiority, Controlled, Randomized, Single-blind Study for Compare Regimens of One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole to Treat Chronic Fascioliasis |
Estimated Study Start Date : | July 2024 |
Estimated Primary Completion Date : | March 2028 |
Estimated Study Completion Date : | March 2028 |
Arm | Intervention/treatment |
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Experimental: Study arm 1
Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.
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Drug: Oxfendazole
Human studies have shown that doses up to 60 mg/kg (approximately 3.6 g for a 60-kg human, which is considered the average weight of an adult in developing countries) are safe and that repeated doses of 15 mg/kg (approximately 900 mg for a 60-kg human) daily for 5 days are safe. A single dose of OXF results in significant plasma drug concentrations that reach a Cmax plateau after doses of 15 mg/kg.75 The dose to be studied in this trial is 20 mg/kg (1200 mg maximum dose), a dose only slightly higher than that achieving a Cmax plateau. This dose was conservatively selected to account for interindividual variation in plasma levels and deemed well tolerated and safe based on laboratory and ECG evaluations.
Other Names:
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Experimental: Study arm 2
Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.
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Drug: Oxfendazole
Human studies have shown that doses up to 60 mg/kg (approximately 3.6 g for a 60-kg human, which is considered the average weight of an adult in developing countries) are safe and that repeated doses of 15 mg/kg (approximately 900 mg for a 60-kg human) daily for 5 days are safe. A single dose of OXF results in significant plasma drug concentrations that reach a Cmax plateau after doses of 15 mg/kg.75 The dose to be studied in this trial is 20 mg/kg (1200 mg maximum dose), a dose only slightly higher than that achieving a Cmax plateau. This dose was conservatively selected to account for interindividual variation in plasma levels and deemed well tolerated and safe based on laboratory and ECG evaluations.
Other Names:
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Active Comparator: Study arm 3
Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.
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Drug: Triclabendazole
The standard of care for the treatment of fascioliasis according to the same guidelines is two 10 mg/kg doses of TCBZ 24 hours apart administered with a fat containing meal. The subjects in one of the arms of the study will receive this treatment as the standard of care. Subjects from any of the arms that fail to achieve parasitological cure will receive rescue treatment off the study with two doses of TCBZ as recommended by the Peruvian guidelines.
Other Name: Egaten |
- Parasitological cure rate of chronic fascioliasis [ Time Frame: At day 30 post-treatment. ]The cure rate will be expressed as the proportion of subjects in each arm with negative tests for Fasciola eggs.
- Egg reduction rate day 7 [ Time Frame: At day 7 post-treatment. ]The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count
- Egg reduction rate day 30 [ Time Frame: At day 30 post-treatment. ]The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count
- Safety information on day 0 [ Time Frame: Day 0 after first dose of study medication. ]Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
- Safety information on day 3 [ Time Frame: Day 3 after first dose of study medication. ]Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
- Safety information on day 7 [ Time Frame: Day 7 after first dose of study medication. ]Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
- Safety information on day 30 [ Time Frame: Day 30 after first dose of study medication. ]Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
- Laboratory safety information day 7 [ Time Frame: Day 7 after first dose of study medication ]Safety information will be assessed using laboratory testing and expressed as the proportion of subjects in each arm with abnormal values.
- Laboratory safety information day 30 [ Time Frame: Day 30 after first dose of study medication ]Safety information will be assessed using laboratory testing and expressed as the proportion of subjects in each arm with abnormal values.
- Population pharmacokinetics model constructs for oxfendazole [ Time Frame: Day 0 ]The plasma levels of oxfendazole will be expressed as a scale using a unit of mass over a unit of volume (micrograms/microliter) and modeled with a population-based approach to assess the disposition and exposure to these drugs forms.
- Population pharmacokinetics model constructs for oxfendazole sulfone [ Time Frame: Day 0 ]The plasma levels of oxfendazole sulfone will be expressed as a scale using a unit of mass over a unit of volume (micrograms/microliter) and modeled with a population-based approach to assess the disposition and exposure to these drugs forms.
- Population pharmacokinetics model constructs fenbendazole [ Time Frame: Day 0 ]The plasma levels of fenbendazole will be expressed as a scale using a unit of mass over a unit of volume (micrograms/microliter) and modeled with a population-based approach to assess the disposition and exposure to these drugs forms.
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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female subjects twelve years or older with positive stool microscopy and/or egg counts.
- Subjects capable of understanding the informed consent process and providing written informed consent. In the case of children, the parents will be asked to consent for their child's participation and the child will be asked to assent to participate.
- Willingness to give informed consent if the volunteer is 18 years of age or older, or assent if the volunteer is a minor between 12 and 17.
Exclusion Criteria:
- Subjects reporting previous treatment for fascioliasis
- Subjects with a stool egg count > 300 eggs/g stool
- Women with a positive urine pregnancy test or planning to become pregnant
- Women that are nursing
- ALT ≥ 3 or AST ≥ 3 times above the upper limit of normal
- Subjects with active cerebral cysticercosis determined by serology and imaging studies
- Subjects with known liver disease, liver cirrhosis, or end stage renal disease
- Subjects with known allergy or AEs to benzimidazole drugs
- Subjects taking carbamazepine, phenobarbital, phenytoin, or other medication known to decrease the serum concentrations of benzimidazoles.
- Women unable or unwilling to use an acceptable birth control method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06367361
Contact: Miguel M Cabada, MD MSc | +1 409 747 0236 | micabada@utmb.edu | |
Contact: Hector H Garcia, MD PhD | (511) 328-7360 | hgarcia1@jhu.edu |
Study Chair: | Miguel M Cabada, MD MSc | University of Texas | |
Principal Investigator: | Lourdes Rodriguez, MD | Asociacion CerviCusco | |
Study Chair: | Hector H Garcia, MD PhD | Universidad Peruana Cayetano Heredia |
Responsible Party: | Universidad Peruana Cayetano Heredia |
ClinicalTrials.gov Identifier: | NCT06367361 |
Other Study ID Numbers: |
SIDISI 201221 U01AI155323 ( U.S. NIH Grant/Contract ) |
First Posted: | April 16, 2024 Key Record Dates |
Last Update Posted: | April 16, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Fascioliasis Trematode Infections Helminthiasis Parasitic Diseases Infections Liver Diseases, Parasitic Liver Diseases Digestive System Diseases |
Oxfendazole Triclabendazole Fenbendazole Anthelmintics Antiparasitic Agents Anti-Infective Agents Antinematodal Agents Antiplatyhelmintic Agents |