An Expanded Access Study Of Sofosbuvir Combined With Ribavirin And Either With Or Without Pegylated Interferon For Treating Aggressive Post-Transplant Hepatitis C
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 13-005608
NCT ID: NCT01779518
Sponsor Protocol Number: GS-US-334-0139
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