Status:
COMPLETED
Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients
Lead Sponsor:
King Abdulaziz Medical City
Collaborating Sponsors:
Riyadh Military Hospital
King Faisal Specialist Hospital & Research Center
Conditions:
Chronic Hepatitis C
Renal Transplant
Eligibility:
All Genders
18-68 years
Phase:
PHASE4
Brief Summary
There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Small case serie...
Eligibility Criteria
Inclusion
- Patients, male and female, aged 18 - 68 years
- Post renal transplant patients exceeding one year
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \> 6 months AND/OR
- Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with lower limit of detection at 50 IU/mL
- Compensated liver disease with the following minimum hematologic and biochemical criteria:
- Hemoglobin \> 10 g/dL
- WBC \> 3000/mm3 ; granulocyte count \> 1,500/mm3
- Platelet count \> 75,000/mm3
- Albumin within normal limits
- TFT within normal limits
- ANA \< 1:320
- Ultrasound of the liver obtained within the preceding 6 months of study entry
- Liver biopsy prior to entry confirming a histological diagnosis consistent with HCV necroinflammatory score (METAVIR) \> 1, and fibrosis score \>/= 2.
Exclusion
- Previous treatment with interferon and / or Ribavirin - based therapy for chronic hepatitis C
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption \> 20 g/day)
- Autoimmune or metabolic liver disease liver disease
- Active drug-induced hepatitis or HAV
- Decompensated liver disease (Child-Pugh classification B or C) including a past history of decompensation
- Variceal bleeding
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitis or hypertension
- Neoplastic disease
- Patients with a value of alpha-fetoprotein \>100 ng/mL will be excluded from the study until imaging studies confirm the absence of HCC. Presence of HCC, as determined by other means will also exclude the patient from histological sampling.
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Current pregnancy, ongoing breast feeding or unwilling to have contraception
- Bleeding or clotting diatheses
- Recent history of renal allograft rejection (\< 6 months)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- History of organ transplantation, other than kidney, with an existing functional graft.
- Patients requiring dialysis or in whom dialysis is impending.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00881582
Start Date
January 1 2009
End Date
December 1 2011
Last Update
September 14 2012
Active Locations (2)
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1
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11159
2
Riyadh Military Hospital
Riyadh, Saudi Arabia, 11159