EUCTR2014-002317-32-ITActive, not recruitingNot Applicable
An Open-Label Study to Explore the Clinical Efficacy of GS 7977 (Sofosbuvir -Sovaldi®) with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infection
Azienda Ospedaliera Papa Giovanni XXIII0 sites50 target enrollmentStarted: September 26, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Males or females, age > 18 years old
- •-All transplant patients with HCV active infection at the time of OLT
- •-All genotypes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •-Patients unable to receive oral therapy
- •-< 6 months from previous DAA treatment
- •-CrCl <30ml/min (MDRD or CKD-EPI)
- •-HIV and/or HBV coinfection
Investigators
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