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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002317-32-IT

Enrollment

Registered

2014-09-26

Start date

2014-10-29

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV active infection at the time of OLT

Interventions

Trade Name: Sovaldi Product Name: Sofosbuvir Pharmaceutical Form: Coated tablet Trade Name: Copegus- Rebetol- Ribavirina Sandoz- Ribavirina Teva Product Name: Ribavirina Pharmaceutical Form: Coated t

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if the administration of a combination of GS 7977 and ribavirin to post-OLT HCV subjects for 24 weeks can prevent post-transplant HCV re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant ;Secondary Objective: • Effect of treatment on HCV-related liver disease histology at 1-year • To evaluate the HCV RNA viral kinetics during the initial treatment phase (2 weeks, 4 weeks, 8 weeks) and correlation with response rate Evaluate, from the perspective of the Italian NHS, the overall healthcare cost of the pre-emptive treatment with sofosbuvir and ribavirin of post- LT HCV patients during the observational period. The collectionof these data will allow to compare, in a descriptive way, these costs vs those of patients, with similar characteristics, treated according the current routine practice. ;Primary end point(s): •Post-treatment sustained virological response (pTVR): SVR12 ;Timepoint(s) of evaluation of this end point: 12 week	—

Measure

Time frame

Main Objective: To determine if the administration of a combination of GS 7977 and ribavirin to post-OLT HCV subjects for 24 weeks can prevent post-transplant HCV re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant ;Secondary Objective: • Effect of treatment on HCV-related liver disease histology at 1-year • To evaluate the HCV RNA viral kinetics during the initial treatment phase (2 weeks, 4 weeks, 8 weeks) and correlation with response rate Evaluate, from the perspective of the Italian NHS, the overall healthcare cost of the pre-emptive treatment with sofosbuvir and ribavirin of post- LT HCV patients during the observational period. The collectionof these data will allow to compare, in a descriptive way, these costs vs those of patients, with similar characteristics, treated according the current routine practice. ;Primary end point(s): •Post-treatment sustained virological response (pTVR): SVR12 ;Timepoint(s) of evaluation of this end point: 12 week

—

Secondary

Measure	Time frame
Secondary end point(s): •Post-treatment sustained virological response (pTVR): SVR24; •Histology at 1-year post-OLT •Healthcare resource consumption due to drug treatments, diagnostic services, specialist visits, lab tests, hospitalisations) ;Timepoint(s) of evaluation of this end point: 24 week	—

Countries

Italy

Contacts

Public ContactStefano Fagiuoli

Azienda Ospedaliera Papa Giovanni XXIII

sfagiuoli@hpg23.it00390352674259

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026