Status:
COMPLETED
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatitis C
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatiti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
- Immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
- Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening
- Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.
- Exclusion criteria:
- Serum creatinine \>150 μmol/L (1.6 7 mg/dL) or eGFR \< 50 ml/min (4-variable Modification of Diet in Renal Disease \[MDRD Cockcroft-Gault formula\])
- Multi-organ transplant recipients
- Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or \>1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
- Evidence of conditions that could cause graft dysfunction other than HCV infection
- Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \<3.5g/dL or, total direct bilirubin \>1.5mg/dL or, INR \>1.5)
- Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening
- Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
- Antiviral treatment for HCV administered at any time after liver transplantation
- Patients on daily doses of corticosteroids higher than 5 mg/day
- Patients with fibrosing cholestatic hepatitis
- Patients with current diagnosis of malignancies, including lymphoproliferative disorders
- Patients with platelet count \<70,000/mm3 or neutrophiles \<1,500/mm3
- History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00938860
Start Date
September 1 2009
End Date
May 1 2013
Last Update
May 22 2015
Active Locations (45)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85054
2
Novartis Investigative Site
Palo Alto, California, United States, 95128
3
Novartis Investigative Site
San Francisco, California, United States, 94143-2205
4
Novartis Investigative Site
Gainesville, Florida, United States, 32610