Clinical trial for Hepatitis C
Official title Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir
ClinicalTrials.gov ID: NCT03855917
What this study is testing
What is Sofosbuvir 400mg [Sovaldi]?
Sofosbuvir 400mg [Sovaldi] is an investigational medicine, being studied as a potential treatment for hepatitis c.
Also referred to as Sovaldi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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-pibrentasvir for 12 weeks, in treatment-naïve participants with chronic HCV infection and early liver disease (F0-F2).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Participants must meet all 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- \- Participants must meet all 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Sydney, New South Wales, Australia; Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.