Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel

NCT07074444 | Recruiting Phase 4

• 1 other identifier: 2025-K0110
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate and compare the efficacy and safety of three commonly used antiparasitic drugs-albendazole, tribendimidine, and praziquantel-for the treatment of clonorchiasis, a liver fluke infection acquired by consuming raw or undercooked freshwater fish. This study aims to answer the following primary questions: How effective is each drug in achieving parasitological cure, as measured by clearance of Clonorchis sinensis eggs in stool? What types and frequencies of adverse events are associated with each treatment? Participants in this randomized, open-label trial will: Be randomly assigned to receive one of the three study drugs according to a predefined dosing regimen. Provide stool samples before treatment and at follow-up to assess for Clonorchis sinensis eggs. Undergo a second round of the same treatment regimen and repeated stool examination if eggs are still detected after the first course. Attend follow-up visits, which include symptom assessment, blood tests (hematology and liver function), and abdominal ultrasonography focusing on hepatobiliary changes. Report any side effects, discomfort, or adverse reactions experienced during or after treatment. The findings from this study will help inform optimal therapeutic strategies for clonorchiasis in outpatient clinical settings.

Conditions

Clonorchiasis

Keywords

Clonorchiasis; Albendazole; Praziquantel; Egg clearance rate; tribendimidine

Outcome Measures

Primary Outcomes (1)

• Egg Clearance Rate

  The primary outcome is the proportion of participants who test negative for Clonorchis sinensis eggs in all three stool samples collected at different time points post-treatment.

  From Day 30 to Day 60 after the last dose of treatment

Secondary Outcomes (5)

• Symptom Improvement Rate

  Baseline and Day 31 (±1 day) after the last dose of treatment

• Hepatobiliary Ultrasonographic Improvement

  Baseline and Day 31 (±1 day) after the last dose of treatment

• Adverse Events (AEs)

  From first dose to Day 30 (±1day) after the last dose of treatment

• Proportion of Abnormal Hematology and Liver Function Results

  Baseline and Day 31(±1 day) after the last dose of treatment

• Drug Intolerance Rate

  From first dose to Day 31 (+1 day) after the last dose of treatment

Other Outcomes (1)

• Egg Clearance Rate After Second Treatment

  From Day 30 to Day 60 after the last dose of second treatment]

Study Arms (3)

Praziquantel

ACTIVE COMPARATOR

Praziquantel tablets: Administer orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet according to the physician's recommendation.

Drug: praziquantel

Albendazole

EXPERIMENTAL

Albendazole tablets: Administer orally at 10 mg/kg/day for 7 consecutive days. The daily dose will be administered in two divided doses. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the actual dose may be adjusted to the nearest whole tablet. The specific dose will be adjusted according to the physician's recommendation.

Drug: Albendazole

Tribendimidine

EXPERIMENTAL

Tribendimidine enteric-coated tablets: Administer orally at 0.4 g once daily (QD) for 3 consecutive days.

Drug: Tribendimidine

Interventions

Albendazole DRUG

Participants receive albendazole tablets orally at a total daily dose of 10 mg/kg for 7 consecutive days. The daily dose will be administered in two divided doses. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.

Albendazole

Tribendimidine DRUG

Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.

Tribendimidine

praziquantel DRUG

Participants receive praziquantel tablets orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.

Praziquantel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years.
• Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.
• Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if:

• Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
• Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
• Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
• Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
• Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
• Pregnant or breastfeeding individuals, or those of reproductive potential (male or female) who are unwilling to use effective contraception during the study period and for 3 months following the last dose of study medication.
• Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control: collaborator

Study Sites (2)

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Clonorchiasis

Interventions

Albendazole; tribendimidine; Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines

Study Officials

• Hongliang Zhang

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongliang Zhang

CONTACT

+86 13737143253; 277749097@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 20, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication, available upon request for 3 years.
• Access Criteria: Researchers can gain access to the individual participant data (IPD) and supporting information by submitting a data sharing request proposal. The proposal must include a description of the planned analyses, including the statistical methods to be used. Proposals will be reviewed by an independent data access committee to ensure that the analyses are aligned with the study's objectives and meet ethical and scientific standards. To gain access, researchers must sign a data sharing agreement, which outlines the terms of use, including the intended use of the data, and any conditions for publication of results. Data sharing requests will be reviewed on a rolling basis, and researchers will be notified of the decision within 60 days of submission.

Locations

CN (2)