Trial record 1 of 1 for:    NCT00938860
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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: April 25, 2014
Last verified: April 2014

July 13, 2009
April 25, 2014
September 2009
May 2013   (final data collection date for primary outcome measure)
Number of Participants Sustained Virological Response (SVR) Following Treatment of Recurrent HCV Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Immunosuppressive Therapy Either With Neoral or Tacrolimus [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment
Sustained Virological Response as measured by HCV RNA by PCR [ Time Frame: 80 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00938860 on ClinicalTrials.gov Archive Site
  • Number of Events to Compare the Rates of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death
  • Number of Participants to Assess the Rate of Fibrosis Progression (Ishak-Knodell Score) [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite
  • Number of Participants to Compare Rates of Rapid Viral Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment
  • Number of Participants to Compare Rates of Early Viral Response (EVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment
  • Number of Participants Considered to Compare the End of Treatment Response (ETR) [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    ETR defined as non-detectable HCV RNA at the completion of AV treatment
  • Number of Participants Considered to Compare the Rates of Virological Response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Virological response (i.e., non-detectable HCV RNA) after 12 weeks of initiation of antiviral treatment; early virological response (EVR)
  • Number of Participants Considered to Analyze the True Non-responder Rate [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Defined as failure to achieve at least a 2 log reduction of HCV RNA
  • Number of Participants Considered to Analyze the Relapse Rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Defined as reappearance of detectable HCV RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment
  • Number of Participants Analyzied to Compare the Rate of Patients With Dose Reduction or Discontinuation of AV Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability
  • 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 ]
Not Provided
Not Provided
 
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Liver Transplantation
  • Drug: cyclosporin (Neoral)
    Neoral capsules bid, dose adjusted according to blood concentrations given for entire duration of study (80 weeks).
  • Drug: tacrolimus
    Tacrolimus capsules bid, dosed according to blood concentrations, given for entire duration of study(80 weeks).
  • Experimental: Neoral and standard antiviral treatment
    Intervention: Drug: cyclosporin (Neoral)
  • Active Comparator: tacrolimus + standard antiviral treatment
    Intervention: Drug: tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   Colombia,   France,   Germany,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Switzerland,   United Kingdom
 
NCT00938860
COLO400A2430, 2009-010806-12
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP