Clinical Efficacy of Sofosbuvir with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infectio

• Conditions: HCV active infection at the time of OLT; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002317-32-IT
• Lead Sponsor: Azienda Ospedaliera Papa Giovanni XXIII

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-26
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified