NCT07754617Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2029
- Lead sponsor
- Rhode Island Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07754617
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 600
- From Nov 2026 to the primary completion date, Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- . 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
Other
- Known neurocysticercosis or ocular cysticercosis
Who the study is looking for
- 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.
Age in the registry: 15 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uganda Virus Research Institute Coordinator of this site? Confirm its status | Entebbe | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.