Short-term treatment for early liver disease caused by Hepatitis C

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of a 4-week treatment regimen combining sofosbuvir with glecaprevir-pibrentasvir for patients with chronic Hepatitis C and early liver disease. Participants who experience a virological relapse will receive immediate retreatment with glecaprevir-pibrentasvir for an additional 12 weeks. The study aims to determine if this shortened therapy can effectively eliminate the virus while maintaining safety and feasibility. The approach leverages a next-generation direct acting antiviral regimen known for its high efficacy and pangenotypic activity.

Why it matters

Who can join: the full rules

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.

Where it's running

• St Vincent's Hospital
  Darlinghurst, New South Wales, Australia Recruiting
• Blacktown Mt Druitt Hospital
  Sydney, New South Wales, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Marianne Martinello, MD, PhD — Kirby Institute
• Study coordinator: Marianne Martinello, MD, PhD
• Email: mmartinello@kirby.unsw.edu.au
• Phone: +61293850900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glecaprevir/pibrentasvir started during pregnancy for women with hepatitis C, with or without HIV

  This trial will test whether taking glecaprevir/pibrentasvir during pregnancy is safe and how the drug is processed in pregnant women who have hepatitis C, including those who also have HIV, and will follow their infants for 10 weeks after birth.

  Recruiting at 8 sites Phase 1/2 National Institute of Allergy and Infectious Diseases (NIAID) · Los Angeles, California and 9 other locations · NCT07040319

• Evaluating hepatitis C treatment during pregnancy

  This study tests how well a new hepatitis C treatment works for pregnant adults with a history of drug use and looks at their experience during the treatment.

  Recruiting at 2 sites Washington University School of Medicine · St Louis, Missouri and 1 other locations · NCT06367465

• Decentralized treatment for hepatitis C in Brazil

  This study is testing a new way to treat hepatitis C in Brazil using a medication called Epclusa to see if it helps more people get the care they need compared to traditional methods.

  Recruiting at 2 sites Phase 4 Oswaldo Cruz Foundation · Rio de Janeiro, Rio de Janeiro and 1 other locations · NCT06306300

• Helping young people who inject drugs start treatment for Hepatitis C

  This study tests a new support program to help young adults who inject drugs start treatment for Hepatitis C and see if it works better than regular care.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06179498

• Simplified hepatitis C testing with same-day treatment for people who inject drugs in Armenia, Georgia and Tanzania

  This project will test whether a simplified pathway that starts hepatitis C treatment the same day after a quick antibody test helps people who inject drugs in Armenia, Georgia, and Tanzania get treated and cured faster than the usual antibody-plus-RNA pathway.

  Recruiting Early Phase 1 Médecins du Monde · Yerevan · NCT06159504

• Point-of-care testing program for Hepatitis C screening

  This study is testing if quick Hepatitis C tests done during a single visit can help more at-risk adults get diagnosed and start treatment faster.

  Recruiting at 6 sites Kirby Institute · Canberra, Australian Capital Territory and 12 other locations · NCT05713136

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.