EUCTR2012-000637-39-ESActive, not recruitingNot Applicable
An Open-Label Study to Explore the Clinical Efficacy of GS-7977 with Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Gilead Sciences Inc.
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Willing and able to provide written informed consent
- •2. Males or females, age > 18 years old
- •3. Confirmation of chronic HCV infection
- •4. HCV RNA > 104 IU/mL at Screening
- •5. Patients meeting the MILAN criteria undergoing liver transplant for HCC secondary to HCV with a MELD of <22 and a HCC weighted MELD of ?22.
- •6. Child-Pugh Score (CPT) ? 7
- •7. Planned management of the subject to meet UNOS criteria, with imaging studies made available for review if required
- •8. A body mass index (BMI) of ?18 kg/m2.
- •9. Screening ECG without significant clinical abnormalities with a QTc ? 500 ms with no personal or family history of Torsades de pointes
- •11. Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
Exclusion Criteria
- •1. Prior exposure to a direct-acting antiviral targeting the HCV NS5b polymerase
- •2. Any transplant patient who has agreed to a liver transplant from a live donor
- •3. Subjects requiring planned induction therapy with biologics post-transplantation or with a post-transplantation immunosuppressive regimen
- •4. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome, among other signs of decompensated cirrhosis
- •5. Recent (within 4 weeks of screening) episode of infection requiring systemic antibiotics
- •6. Pregnant or nursing female or male with pregnant female partner
- •7. Chronic liver disease of a non-HCV etiology
- •8. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •9. Contraindications to RBV therapy
- •10. History of malignancy diagnosed or treated within 5 years
- •11. History of clinically significant hemoglobinopathy
- •12. Chronic use of systemically administered immunosuppressive agents
- •13. History of previous solid organ transplantation
- •14. Evidence of renal impairment
Investigators
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