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Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis

NCT07754617 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-08-12

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are:

1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years.
2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years.
3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens.

Participants will:

Be screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial

If they are in the trial they will:

Take the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year

Conditions

  • Schistosomiasis
  • Schistosoma Mansoni
  • Liver Fibrosis
  • Portal Hypertension

Interventions

DRUG

Praziquantel 40 mg/kg per dose given once annually

Standard recommended by World Health Organization (annual treatment)

DRUG

Praziquantel 40 mg/kg given three times per year

This intervention provides Praziquantel treatment three times per year (enhanced frequency compared to current WHO guidelines)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • Rhode Island Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-11-30
Completion
2029-11-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754617 on ClinicalTrials.gov