Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C
NCT ID: NCT00275548
Last Updated: 2011-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2004-07-31
2009-04-30
Brief Summary
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Detailed Description
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Participants will be put into one of two groups. In the preventive group; participants will receive study drugs for the treatment of recurring (or returning) hepatitis C before developing actual clinical symptoms. The participants in the observational groups will receive study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis c infection.
This study will have four parts: a screening phrase, a treatment/observational phrase, follow-up phase and long term safety follow-up phase. Throughout all four stages of the study, participants will have physical exams, medical and surgical history's will be taken, blood and urine tests, eye exam, liver biopsy, chest x-ray and electrocardiogram (ECG). If participants are female, a pregnancy test will also be performed. Participants must also agree not to drink any alcoholic beverages or take any other drugs for hepatitis c infection while taking part in the study. Participants must be able to return for clinic visits at scheduled intervals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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The Preventative (Prophylaxis) Group:
This group of patients will receive study drugs for the treatment of recurring (or returning) hepatitis C before they actually develop clinical symptoms of hepatitis C.
Pegasys
135-180 micrograms administered sc once weekly
Copegus
400-1200 mg/day for 48 weeks
The Observational Group:
This group of patients will receive the study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis C infection.
Pegasys
135-180 micrograms administered sc once weekly
Copegus
400-1200 mg/day for 48 weeks
Interventions
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Pegasys
135-180 micrograms administered sc once weekly
Copegus
400-1200 mg/day for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 Criteria:
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
19 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Michael R. Charlton, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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1404-04
Identifier Type: -
Identifier Source: org_study_id