Health Trials

Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis

ConditionsSchistosomiasisSchistosoma MansoniLiver FibrosisPortal Hypertension
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Praziquantel 40 mg/kg per dose given once annually

    Drug

    Standard recommended by World Health Organization (annual treatment)

  • Praziquantel 40 mg/kg given three times per year

    Drug

    This intervention provides Praziquantel treatment three times per year (enhanced frequency compared to current WHO guidelines)

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Annual treatment (standard) with PraziquantelOther 1 intervention
Group B: Treatment with Praziquantel three times per yearExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in liver fibrosis grade

The primary outcome will be any improvement in grade of fibrosis (mild, moderate, severe) from baseline to study close out at three years.

Time frame
three years

Secondary outcomes

1

Improvement in Severity of Portal Hypertension

We will assess whether there is evidence of significant portal hypertension by ultrasound as per the Niamey protocol at baseline and annually. The presence of portal hypertension will be defined by the portal vein quotient (adjusted for height). A quotient greater than 7.5 is indicative of portal hypertension. The severity is graded based on the portal vein quotient as absent, dilated or severely dilated. This secondary outcome improvement in severity of portal hypertension that was present at baseline by the three year close out.

Time frame
Three years
2

Improvement in grade of liver fibrosis from baseline to two years

improvement in grade of liver fibrosis after two years

Time frame
Two years
3

Improvement in severity of portal hypertension after two years

Improvement in severity of portal hypertension (absent, dilated or severely dilated) as assessed by ultrasound from baseline to two years

Time frame
Two years
4

Improvement in grade of liver fibrosis at one year

Improvement in grade of liver fibrosis as assessed by ultrasound from baseline to one year

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

MRC/UVRI and LSHTM Uganda Research Unit

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: