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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00938860
First received: July 13, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Liver Transplantation
Drug: cyclosporin (Neoral)
Drug: tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sustained Virological Response as measured by HCV RNA by PCR [ Time Frame: 80 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare rates of the composite endpoint of biopsy proven rejections (BPAR) death or graft loss [ Time Frame: Week 80 (EOS) ] [ Designated as safety issue: No ]
  • Assess the rate of fibrosis progression (Ishak-Knodell score) [ Time Frame: Week 80 (Eos) ] [ Designated as safety issue: No ]
  • Compare rates of Rapid Viral Response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Compare rates of Early Viral Response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Compare the End of Treatment Response [ Time Frame: Week 80 (EoS) ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoral and standard antiviral treatment Drug: cyclosporin (Neoral)
Neoral capsules bid, dose adjusted according to blood concentrations given for entire duration of study (80 weeks).
Active Comparator: tacrolimus + standard antiviral treatment Drug: tacrolimus
Tacrolimus capsules bid, dosed according to blood concentrations, given for entire duration of study(80 weeks).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver transplantation performed at least 6 months and up to 10 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
  • Immunosuppressive regimen based on tacrolimus - (twice or once daily) for at least 6 months prior randomization
  • Diagnosis of HCV genotypes 1 or 4 infection confirmed 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 (> 1.7 mg/dL) or eGFR < 50 ml/min ([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 direct bilirubin >2 ULN, 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 neutrophils < 1,500/mm3
  • History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938860

  Show 45 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00938860     History of Changes
Other Study ID Numbers: COLO400A2430, 2009-010806-12
Study First Received: July 13, 2009
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Ministry of Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Korea: Food and Drug Administration
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Hepatitis C
liver transplantation
anti-viral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Cyclosporins
Cyclosporine
Tacrolimus
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014