Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00938860
• Date of registration: 13/07/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C SUSTAIN
• Scientific title: A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C
• Date of first enrolment: September 2009
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00938860
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Belgium, Brazil, Canada, Colombia, France, Germany, Italy, Korea, Republic of, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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 < 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Transplantation

Hepatitis C

Intervention(s)

Drug: tacrolimus (Prograf)

Drug: cyclosporin (Neoral)

Primary Outcome(s)

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 [Time Frame: Week 24]

Secondary Outcome(s)

Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components [Time Frame: Week 80]

Number of Participants for Relapse Rate [Time Frame: Week 24]

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 [Time Frame: Week 80]

Number of Participants of Rapid Viral Response (RVR) [Time Frame: Week 4]

Number of Participants of True Non-responder Rate [Time Frame: Week 80]

Number of Participants for the End of Treatment Response (ETR) [Time Frame: Week 80]

Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline) [Time Frame: Week 80]

Number of Participants of Early Viral Response (EVR) [Time Frame: Week 12]

Secondary ID(s)

COLO400A2430

2009-010806-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00938860