Status:
COMPLETED
Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Liver Transplant
Hepatitis C
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infecti...
Detailed Description
This is a multicenter, prospective, randomized, open-label efficacy and safety study. The study is being done to see whether treatment using Pegasys (pegylated interferon alfa-2a) and Copegus (ribavir...
Eligibility Criteria
Inclusion
- Positive HCV RNA by PCR at pretransplantation. No biochemical inclusion criteria Male or female patient (\>18 yrs) who has undergone liver transplantation because of liver cirrhosis attributed to HCV infection. Patient is a primary, single organ recipient (cadaveric donor). Normal thyroid-stimulating hormone (TSH) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Documentation that female patients of childbearing potential and all male patients are practicing two methods of contraception. For male participants, the following methods are acceptable: 1) vasectomy ANDcondoms with spermicide or 2) vasectomy or condoms with spermicide AND a monogamous relationship with a woman using a single method of contraception. Liver transplant \>10 weeks and \<26 weeks (6 months) before treatment initiation Patients with a pre-OLT diagnosis of hepatocellular carcinoma (HCC) may be enrolled provided there is no evidence of extrahepatic spread or vascular invasion, and the tumor is solitary and \<5 cm or there are up to three tumors \<3 cm.
Exclusion
- Multi-organ or retransplant recipient Patients with HCC who do not meet inclusion criteria or require systemic chemotherapy Recipient of ABO incompatible organ Donor cold ischemia time \>20 hrs Anti-HBc positive donor Histological evidence of unresolved rejection Episode of steroid resistant rejection / use of OKT3 Evidence of current Hepatitis B (sAg, cAb, IgM) Seropositivity for HIV infection Serum creatinine \>2x upper limit of normal WBC \>20,000 x 109/L or ANC \<1,500 cells/mm3 Hgb \<10g/dL and/or platelets \<50,000/mm3 History of autoimmune disease (SLE, scleroderma, rheumatoid arthritis etc.) Uncontrolled seizure disorder Uncontrolled depression or history of suicide attempts/ideation History or evidence of retinopathy Unable or unwilling to give informed consent
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00275548
Start Date
July 1 2004
End Date
April 1 2009
Last Update
November 11 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905