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Not Yet Recruiting NCT07754617

Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis

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

Sex: All
Ages: 15 Years – 40 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 600
Sponsor: Rhode Island Hospital

Location: Uganda Virus Research Institute Entebbe

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

Eligibility Criteria

Inclusion Criteria: 1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA) 2. Otherwise healthy as determined by history and physical examination conducted by the study clinician 3. Not Pregnant 4. Age 15-40 years 5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years. 6. 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. Exclusion Criteria: 1. . History of upper gastrointestinal bleeding 2. 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 3. Known neurocysticercosis or ocular cysticercosis

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07754617). StuddyBuddy aggregates publicly available trial information.