NCT01779518

Brief Summary

This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

First QC Date

January 23, 2013

Last Update Submit

January 15, 2014

Conditions

Post-transplant Hepatitis C

Keywords

HCVSustained Virologic ResponseDirect Acting AntiviralGS-7977Pegylated interferonRibavirinOpen LabelSofosbuvirLiver transplantHepatitisHepatitis, ChronicHepatitis CHepatitis C, ChronicLiver DiseasesDigestive System DiseasesHepatitis, Viral, HumanVirus DiseasesEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsFlaviviridae InfectionsAntiviral AgentsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsAntimetabolitesMolecular Mechanisms of Pharmacological Action

Interventions

SofosbuvirDRUG
Also known as: GS-7977, PSI-7977, Sovaldi™
RibavirinDRUG
Pegylated InterferonDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years
  • Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
  • Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
  • Life expectancy of \< 12 months if the HCV is left untreated

You may not qualify if:

  • History of clinically significant drug allergy to nucleoside/nucleotide analogs
  • Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
  • Unable or unwilling to follow the contraception requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HepatitisHepatitis, ChronicHepatitis CHepatitis C, ChronicLiver DiseasesDigestive System DiseasesHepatitis, Viral, HumanVirus DiseasesEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsFlaviviridae Infections

Interventions

SofosbuvirRibavirin

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfections

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 30, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01