NCT07262814

Brief Summary

This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel 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 6-7 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

November 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

November 20, 2025

Last Update Submit

March 17, 2026

Conditions

Opisthorchis Viverrini

Outcome Measures

Primary Outcomes (1)

  • Cure rate (CR) of arpraziquantel against O. viverrini

    CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment.

    21-28 days after treatment

Secondary Outcomes (2)

  • Egg reduction rates (ERR) of arpraziquantel against O. viverrini

    21-28 days after treatment

  • Safety and tolerability of the different arpraziquantel dosing regimens, and compared to placebo

    3 hours, 24 hours, 21-28 days and 42 days after treatment

Study Arms (5)

Arpraziquantel 30 mg/kg

EXPERIMENTAL

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

Drug: Apraziquantel

Arpraziquantel 40 mg/kg

EXPERIMENTAL

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

Drug: Apraziquantel

Arpraziquantel 50 mg/kg

EXPERIMENTAL

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

Drug: Apraziquantel

Arpraziquantel 60 mg/kg

EXPERIMENTAL

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

Drug: Apraziquantel

Arpraziquantel 20 mg/kg

EXPERIMENTAL

Treatment with a single dose arpraziquantel: 20 mg/kg, orally administered

Drug: Apraziquantel

Interventions

ApraziquantelDRUG

Tablets (dispersible) containing 150 mg arpraziquantel

Arpraziquantel 20 mg/kgArpraziquantel 30 mg/kgArpraziquantel 40 mg/kgArpraziquantel 50 mg/kgArpraziquantel 60 mg/kg

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6 to 7 years (i.e., 72 to 95 months).
  • 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 21-28 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lao Tropical and Public Health Institute (Lao TPHI)

Vientiane, Laos

Location

Central Study Contacts

Jennifer Keiser, PhD

CONTACT

+41 61 284 82 18jennifer.keiser@swisstph.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 4, 2025

Study Start

April 15, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)