Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C (SUSTAIN)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00938860
First received: July 13, 2009
Last updated: January 15, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 355 |
| Study Start Date: | June 2009 |
| Estimated 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 22 Study Locations
Show 22 Study LocationsSponsors 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 |
| Study First Received: | July 13, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | 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 United States: Food and Drug Administration |
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 May 19, 2013