Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15-40
SponsorRhode Island Hospital

About this trial

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

Qualifiers

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

Disqualifiers

. 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

Trial design

Treatments tested in this trial

  • Praziquantel 40 mg/kg per dose given once annually
  • Praziquantel 40 mg/kg given three times per year

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rhode Island Hospital

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

MRC/UVRI and LSHTM Uganda Research Unit

Collaborator