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Clinical Trials/EUCTR2014-002317-32-IT
EUCTR2014-002317-32-IT
Active, not recruiting
Not 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 enrollmentSeptember 26, 2014
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ConditionsHCV active infection at the time of OLTTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsSovaldiCopegus- Rebetol- Ribavirina Sandoz- Ribavirina Teva

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HCV active infection at the time of OLT
Sponsor
Azienda Ospedaliera Papa Giovanni XXIII
Enrollment
50
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 26, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Azienda Ospedaliera Papa Giovanni XXIII

Eligibility 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

  • •\-Patients unable to receive oral therapy
  • •\-\< 6 months from previous DAA treatment
  • •\-CrCl \<30ml/min (MDRD or CKD\-EPI)
  • •\-HIV and/or HBV coinfection

Outcomes

Primary Outcomes

Not specified

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