Status:
COMPLETED
Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Schering-Plough
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Patients awaiting deceased donor liver transplant will be asked to enroll in this protocol at the time of identification of a potential living liver donor (see note note at end of description). Patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00135798
Start Date
September 1 2005
End Date
December 1 2009
Last Update
April 23 2013
Active Locations (8)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095-7054
2
University of California San Francisco
San Francisco, California, United States, 94143-0538
3
University of Colorado
Denver, Colorado, United States, 80262
4
Northwestern University Division of Transplantation
Chicago, Illinois, United States, 60611