Status:
RECRUITING
Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir
Lead Sponsor:
Kirby Institute
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to evaluate the efficacy, safety and feasibility of four weeks of sofosbuvir plus glecaprevir-pibrentasvir, followed by immediate retreatment of virological relapse with glecepravir-pi...
Detailed Description
The capacity to eliminate HCV through rapid direct acting antiviral (DAA) therapy scale-up would be enhanced by shortened duration therapy in key populations. The "next generation" DAA regimen of glec...
Eligibility Criteria
Inclusion
- \- Participants must meet all inclusion criteria to be eligible to participate in this study:
- Have voluntarily signed the informed consent form.
- 18 years of age or older.
- Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
- Quantifiable HCV RNA at screening.
- HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
- Liver fibrosis stage F0-F2, defined by at least one of the following:
- Liver stiffness measurement \<9.5 kPa by transient elastography (FibroScan®)
- AST to platelet ratio index (APRI) \<0.5
- Liver biopsy
- 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.
- Negative pregnancy test at screening and baseline (females of childbearing potential only).
- All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
Exclusion
- Participants who meet any of the exclusion criteria are not to be enrolled in this study.
- History of any of the following:
- 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.
- Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
- Solid organ transplant.
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
- Any of the following lab parameters at screening:
- ALT \> 10 x ULN
- AST \> 10 x ULN
- Direct bilirubin \> ULN
- Platelets \< 150,000/μL (cells/mm3)
- Creatinine clearance (CLcr) \< 50 mL/min
- Albumin \< LLN
- INR \> 1.5 ULN
- Pregnant or breastfeeding female.
- HBV infection (HBsAg positive).
- Use of prohibited concomitant medications as described in protocol section 6.3.
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks).
- 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.
- Any investigational drug ≤6 weeks prior to the first dose of study drug.
- Ongoing severe psychiatric disease as judged by the treating physician.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03855917
Start Date
February 11 2020
End Date
February 1 2026
Last Update
March 6 2024
Active Locations (3)
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1
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
2
Blacktown Mt Druitt Hospital
Sydney, New South Wales, Australia, 2148
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000