Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: Ortho Biotech Clinical Affairs, L.L.C.; Schering-Plough
• Treatments: Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Adult (18 or older)

• LDLT candidate

• HCV RNA positive

• Expected time on treatment is at least 12 weeks

• Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD upgrade for HCC

Exclusion Criteria:

• Severe cytopenia (polymorphonuclear (PMN) leukocytes < 750, OR hemoglobin [Hgb] < 10 g/dL, OR platelet count < 35,000/mm3)

• Uncontrolled depression or psychiatric disease characterized by current symptoms of major depression or other psychiatric disease or increase in medication for major depression or other psychiatric disease within the past three months.

• Uncontrolled cardiopulmonary disease characterized by myocardial infarction, coronary artery bypass graft surgery, Percutaneous coronary intervention, or unstable angina within the past three months.

• Uncontrolled autoimmune disease characterized by current symptoms of autoimmune disease or increase in medications within the last three months.

• Autoimmune hepatitis

• Active substance abuse within 6 months of initiation of treatment

• Known intolerance or serious adverse event during prior therapy with interferon or ribavirin

• Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon plus ribavirin

• Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site investigator

• Serum creatinine >2.2 mg/dL