Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-02-01

Brief Summary

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This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel compared to placebo in children infected with Opisthorchis viverrini. The primary objective is to determine the dose-response relationship in terms of cure rate. This study will involve children aged 2-7 years, since O. viverrini infections often occur in pre-school and school-aged children, and this group is largely left untreated in current public health programs.

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Detailed Description

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Conditions

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Opisthorchis Viverrini

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Arpraziquantel 30 mg/kg

Treatment with a single dose arpraziquantel: 30 mg/kg, orally administered

Group Type EXPERIMENTAL

Apraziquantel

Intervention Type DRUG

Tablets (dispersible) containing 150 mg arpraziquantel

Arpraziquantel 40 mg/kg

Treatment with a single dose arpraziquantel: 40 mg/kg, orally administered

Group Type EXPERIMENTAL

Apraziquantel

Intervention Type DRUG

Tablets (dispersible) containing 150 mg arpraziquantel

Arpraziquantel 50 mg/kg

Treatment with a single dose arpraziquantel: 50 mg/kg, orally administered

Group Type EXPERIMENTAL

Apraziquantel

Intervention Type DRUG

Tablets (dispersible) containing 150 mg arpraziquantel

Arpraziquantel 60 mg/kg

Treatment with a single dose arpraziquantel: 60 mg/kg, orally administered

Group Type EXPERIMENTAL

Apraziquantel

Intervention Type DRUG

Tablets (dispersible) containing 150 mg arpraziquantel

Placebo

Placebo treatment, orally administered

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets containing no active pharmaceutical ingredient (Placebo Tablets)

Interventions

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Apraziquantel

Tablets (dispersible) containing 150 mg arpraziquantel

Intervention Type DRUG

Placebo

Tablets containing no active pharmaceutical ingredient (Placebo Tablets)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 2 to 7 years (i.e., 24 to 95 months).
* Bodyweight ≥ 10.0 kg
* Written informed consent signed by parents/caregivers (signature or thumbprint).
* Agree to comply with study procedures, including provision of two stool samples at baseline and at follow-up assessment 14-21 days after treatment, respectively.
* Willing to be examined by a study physician prior to treatment.
* At least two slides of the quadruple Kato-Katz thick smears positive for O. viverrini.

Exclusion Criteria

* Presence or signs of major systemic illness, e.g. severe anaemia (haemoglobin level of \< 80 g/L according to WHO) upon initial clinical assessment.
* Known or suspected infection with Taenia solium (cysticercosis).
* Known or suspected acute schistosomiasis.
* Abnormal liver and kidney function.
* Use of anthelminthic drugs within 4 weeks before or during study period.
* Being breastfed.
* Known allergy to study medications (i.e. praziquantel or any of the excipients).
* Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
* Concurrent participation in other clinical trials.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No