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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00135798

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

79

Starts

2005-09-01

Expected to finish

2009-12-01

Last updated by the study team

2013-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• Northwestern University Division of Transplantation — Chicago, Illinois, United States
• Columbia University — New York, New York, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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