Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis: an RCT

Starting soon · Phase 2/Phase 3

Conditions studied: Schistosomiasis, Schistosoma Mansoni, Liver Fibrosis, Portal Hypertension

In brief

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 people 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 people 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 people will experience worsening liver fibrosis before this happens. Participants will: Be screened for schistosomiasis using a urine test If they 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

Key facts

Study ID

NCT07754617

Run by

Rhode Island Hospital

People needed

600

Starts

2026-11-01

Expected to finish

2029-11-01

Last updated by the study team

2026-08-10

Who can join

Age: 15 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA)
• Otherwise healthy as determined by history and physical examination conducted by the study clinician
• Not Pregnant
• Age 15-40 years
• Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years.
• The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below.

You may not qualify if…

• . History of upper gastrointestinal bleeding
• Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test
• Known neurocysticercosis or ocular cysticercosis

Where it is running

• Uganda Virus Research Institute — Entebbe, Uganda

Full record on ClinicalTrials.gov

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