An Expanded Access Study of Sofosbuvir Combined with Ribavirin and Either with or without Pegylated Interferon for Treating Aggressive Post-Transplant Hepatitis C

Overview

About this study

The purpose of this study, is to open expanded access at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Patients who have an aggressive, recurring hepatitis C infection following liver transplant, will be given sofosbuvir combined with ribavirin, and pegylated interferon may or may not be added at the discretion of the investigator.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This treatment has been approved for sale to the public

Inclusion Criteria

  • Age ≥ 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

Exclusion Criteria

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Andrew Keaveny, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314526

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