Last updated: March 4, 2024
Sponsor: Kirby Institute
Overall Status: Active - Recruiting
Phase
4
Condition
Hepatitis
Primary Biliary Cholangitis
Liver Disorders
Treatment
Sofosbuvir 400mg [Sovaldi]
Glecaprevir/pibrentasvir (300mg/120mg)
Clinical Study ID
NCT03855917
VHCRP1901
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must meet all inclusion criteria to be eligible to participate in thisstudy:
- 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 greaterthan 6 months.
- Quantifiable HCV RNA at screening.
- HCV treatment naïve (no prior treatment with an approved or investigation anti-HCVmedication).
- 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/mm3and a plasma HIV RNA level below the limit of detection.
- Negative pregnancy test at screening and baseline (females of childbearing potentialonly).
- All fertile females must be using effective contraception during treatment and duringthe 30 days after treatment end.
Exclusion
Exclusion Criteria:
- Participants who meet any of the exclusion criteria are not to be enrolled in thisstudy.
- History of any of the following:
- Clinically significant illness (other than HCV) or any other major medicaldisorder that may interfere with the participant treatment, assessment orcompliance with the protocol; participants currently under evaluation for apotentially clinically significant illness (other than HCV) are alsoexcluded.
- Clinical hepatic decompensation (i.e. ascites, encephalopathy or varicealhaemorrhage).
- Solid organ transplant.
- History of severe, life-threatening or other significant sensitivity to anyexcipients 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 (includingsupraphysiologic doses of steroids and radiation) ≤6 months prior to the firstdose 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 therequirements of the study.
Study Design
Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sofosbuvir 400mg [Sovaldi]
Phase: 4
Study Start date:
February 11, 2020
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
St Vincent's Hospital
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Blacktown Mt Druitt Hospital
Sydney, New South Wales 2148
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
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