Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01467505
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants between the ages of 18 and 65 years
* History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
* Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
* Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response
Exclusion Criteria:
* Documented cirrhosis after liver transplantation
* Ascites or hepatic encephalopathy within 6 months before Screening
* Retransplantation for recurrent hepatitis C
* Treatment for hepatitis C post liver transplantation
* History within the past 3 months of: rejection within 3 months or greater than (\>) 1 rejection within 12 months
* Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (\<5 milligram per day) is permitted
* History within 3 months of any bacterial infection requiring \>1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
* History of post transplant lymphoproliferative disease
* Acceptable laboratory values at Screening as specified in the protocol
* Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
* History of hepatocellular carcinoma with high risk of recurrence
* Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
* Autoimmune-mediated disease
* History of acute pancreatitis within 5 years before the Screening visit
* Prior treatment with an hepatitis C virus (HCV) protease inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01467505
Study Brief:
Protocol Section:
NCT01467505