Clinical Research Directory

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

Sponsor: Rhode Island Hospital

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 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

Official title: An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis

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