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Can extra doses of an old drug reverse liver scarring?

NCT ID NCT07754617

Disease control Sponsor: Rhode Island Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This trial tests whether giving praziquantel three times a year, instead of the standard once a year, can improve liver fibrosis (scarring) caused by schistosomiasis in people aged 15-40 in Uganda. Participants with liver fibrosis will be randomly assigned to one of two treatment schedules and followed for three years with annual ultrasounds and blood tests. The study also looks for a blood test that could predict who will get worse before it happens.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Praziquantel, an approved drug for schistosomiasis, given either once or three times per year.
What this could lead to
If more frequent treatment works, it could offer a simple, low-cost way to slow or reverse liver scarring and prevent dangerous bleeding in millions at risk.
What could go wrong
The trial is still testing the idea, and results may show no added benefit from extra doses. Praziquantel is generally safe but can cause mild side effects like nausea or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease hepatic fibrosis, severe, susceptibility to, due to Schistosoma mansoni infection portal hypertension Schistosoma mansoni infectious disease schistosomiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver fibrosis Portal hypertension Schistosoma mansoni Schistosomiasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Uganda Virus Research Institute

    Entebbe, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.