Phase 4
N=92
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
Hepatitis C · Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00938860 ↗Enrolled (actual)
92
Serious AEs
38.0%
Results posted
May 2014
Primary outcome: Primary: Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus — 12; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- cyclosporin (Neoral) (Drug); tacrolimus (Prograf) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus |
12; 10 | — |
| SECONDARY Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components |
2; 1; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline) |
3; 5 | — |
| SECONDARY Number of Participants of Rapid Viral Response (RVR) |
4; 5 | — |
| SECONDARY Number of Participants of Early Viral Response (EVR) |
28; 30 | — |
| SECONDARY Number of Participants for the End of Treatment Response (ETR) |
24; 27 | — |
| SECONDARY Number of Participants of True Non-responder Rate |
7; 5 | — |
| SECONDARY Number of Participants for Relapse Rate |
5; 7 | — |
| SECONDARY Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason |
25; 0; 10; 0; 0; 23 | — |
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 Hepatitis C and treated with Neoral or tacrolimus.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT00938860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.