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Can hepatitis c be cured in just 4 weeks? a new trial puts it to the test

NCT ID NCT03855917

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This pilot study is testing whether a 4-week course of two antiviral drugs—sofosbuvir plus glecaprevir/pibrentasvir—can cure chronic hepatitis C in people who have not been treated before and have only mild liver scarring. Participants who relapse after the short treatment will receive a standard 12-week course of glecaprevir/pibrentasvir. The goal is to see if a shorter, simpler treatment regimen is effective and safe.

What this could mean

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

Active substance
a combination of sofosbuvir and glecaprevir/pibrentasvir
What this could lead to
If successful, this could shorten hepatitis C treatment from the standard 8-12 weeks to just 4 weeks, making cure faster and more convenient.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to everyone. There is a risk of virological relapse after such a short treatment course.

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 people

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

Started

Feb 2020

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: \- Participants must meet all inclusion criteria to be eligible to participate in this study: 1. Have voluntarily signed the informed consent form. 2. 18 years of age or older. 3. Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months. 4. Quantifiable HCV RNA at screening. 5. HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication). 6. Liver fibrosis stage F0-F2, defined by at least one of the following: 1. Liver stiffness measurement \<9.5 kPa by transient elastography (FibroScan®) 2. AST to platelet ratio index (APRI) \<0.5 3. Liver biopsy 7. If co-infection with HIV is documented, the subject must meet the following criteria: * ART naïve with CD4 T cell count \>500 cells/mm3; OR * On a stable ART regimen (containing only permissible ART - see protocol section 6.3) for \>8 weeks prior to screening visit, with CD4 T cell count \>200 cells/mm3 and a plasma HIV RNA level below the limit of detection. 8. Negative pregnancy test at screening and baseline (females of childbearing potential only). 9. All fertile females must be using effective contraception during treatment and during the 30 days after treatment end. Exclusion Criteria: * Participants who meet any of the exclusion criteria are not to be enrolled in this study. 1. History of any of the following: 1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded. 2. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage). 3. Solid organ transplant. 4. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. 2. Any of the following lab parameters at screening: 1. ALT \> 10 x ULN 2. AST \> 10 x ULN 3. Direct bilirubin \> ULN 4. Platelets \< 150,000/μL (cells/mm3) 5. Creatinine clearance (CLcr) \< 50 mL/min 6. Albumin \< LLN 7. INR \> 1.5 ULN 3. Pregnant or breastfeeding female. 4. HBV infection (HBsAg positive). 5. Use of prohibited concomitant medications as described in protocol section 6.3. 6. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks). 7. Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug. 8. Any investigational drug ≤6 weeks prior to the first dose of study drug. 9. Ongoing severe psychiatric disease as judged by the treating physician. 10. Inability or unwillingness to provide informed consent or abide by the requirements of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 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

  • Blacktown Mt Druitt Hospital

    RECRUITING

    Sydney, New South Wales, 2148, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • St Vincent's Hospital

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

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