Status:
WITHDRAWN
Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually comes back. In many patients, this will eventually cause the loss of the new liver and can also confuse the...
Detailed Description
HCV recurs in the transplanted liver almost invariably. The clinical course is variable and ranges from no hepatitis to severe aggressive hepatitis with cirrhosis. Factors that affect outcome are high...
Eligibility Criteria
Inclusion
- Adult male or female patients between 18 and 70 years of age
- All liver transplant patients with a positive HCV RNA by PCR within 30 days after transplant.
- No evidence of acute or chronic rejection within 4 weeks of enrollment
- Compensated liver disease according to the following criteria:
- Hemoglobin \> 10 gm/dL;
- Neutrophil count \> 1,000/mm3;
- Platelet count \> 50,000/mm3;
- Serum creatinine \< 2.0 mg/dL.
- Documentation of adequate contraception in females and males sexually active or of childbearing potential.
Exclusion
- Hypersensitivity to alpha interferon and/or ribavirin
- Previous treatment with interferon and/or ribavirin post liver transplantation
- HIV
- Autoimmune hepatitis
- Active alcohol or substance abuse
- Non compliance
- Hemoglobinopathies or hemolytic anemia
- Clinical significant retinal abnormalities
- Decompensated cardio-vascular, endocrine, pulmonary, renal, immune, metabolic, dermatologic or psychiatric illness
- Re-transplantation
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00167557
Start Date
January 1 2005
End Date
March 1 2008
Last Update
November 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Hermann Hospital
Houston, Texas, United States, 77030