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Could family clinics cure hepatitis c as well as specialists?

NCT ID NCT06306300

Disease control Sponsor: Oswaldo Cruz Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether treating hepatitis C in primary care clinics, with non-specialist doctors, works as well as the standard specialist care in Brazil. It also evaluates the use of rapid tests and self-testing to find more people with the infection. The goal is to see if a simpler, more accessible approach can help more people achieve a cure.

What this could mean

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

Active substance
sofosbuvir/velpatasvir (Epclusa) tablets, with or without specialist follow-up
What this could lead to
If simplified treatment works as well as specialist care, it could make hepatitis C cure accessible to many more people in Brazil and similar settings.
What could go wrong
The trial is large but still needs to show that non-specialist care is truly non-inferior; adherence and follow-up in primary care may be challenging, and results may not generalize beyond Brazil's health system.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30,000 people

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

Started

Jul 2022

Expected to finish

Dec 2026

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

18 to 79 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Study I and Sub-Study Inclusion Criteria: \- Age between 18-79 years-old Exclusion Criteria: * Presence of a disease that need urgent/emergency treatment and/or acute febrile illness, such as COVID-19, Dengue, Zyca virus infection or Chikungunya * Lack of capacity to sign the informed consent or refuse to participate Study II Inclusion Criteria: * Age between 18 and 79 years old. * Presence of active/chronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA Exclusion Criteria: * Children and adolescents (\< 18 years old) * Pregnancy, defined by a positive β-HCG urinary test * Lactating individuals * Co-infection with HBV or HIV * Regular use of medications with potential drug interactions or contraindication for co-administration with SOF/VEL * Presence of severe acute illness, active neoplasia, solid organ transplant, or use of immunosuppressive medications * Presence of clinical signs of decompensated liver cirrhosis (ascites, hepatic encephalopathy, report of a recent episode of gastrointestinal bleeding within the last 12 weeks)

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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection

As listed by the trial registrant

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

Hepatitis C

How to take part

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

  1. The places running it

    2 sites. 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

  • Evandro Chagas National Institute of Infectious Diseases

    RECRUITING

    Rio de Janeiro, Rio de Janeiro/RJ, 21040-360, Brazil

  • Hugo Perazzo

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, Brazil

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