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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00260208
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
A Multicenter, Randomized, Open-label Study to Compare the Development of Liver Fibrosis at 12 Months After Transplantation for Hepatitis C Cirrhosis in Patients Receiving Either Cyclosporine Microemulsion or Tacrolimus
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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New Jersey
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East Hanover, New Jersey, Estados Unidos
- Novartis Investigative Site
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Zurich, Suíça, 8091
- Novartis Investigational site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria
- Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis
- Patients receiving a first liver transplant from a deceased or living donor
- Patients in whom biopsies will be possible
Exclusion criteria
- Recipients of a liver from an hepatitis C virus positive (HCV+), human immunodeficiency virus positive (HIV+) or hepatitis B virus positive (HBV+) donor
- Patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with HBV or HIV
- Patients with co-existing alcoholic disease who have not been abstinent for at least 6 months
- Transplanted for liver cancer exceeding a pre-defined size
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Cyclosporin A
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges. Before enrolling the first patient, each center chose the adjunct immunosuppressive (IS) regimen between:
The regimen selected by the center was to be given to all patients enrolled in the trial from this center. |
Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation.
Outros nomes:
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Comparador Ativo: Tacrolimus
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout study period. Throughout the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain C0 tacrolimus concentrations within target ranges. Before enrolling the first patient, each center chose adjunct immunosuppressive (IS) regimen between:
The regimen selected by center was to be given to all patients enrolled in trial from this center. |
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15
mg/kg/day in 2 divided doses either orally or via a nasogastric (NG) tube or intravenously (i.v).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant
Prazo: 1 year post-transplant
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Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy.
Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis.
Higher score indicates greater fibrosis.
Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.
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1 year post-transplant
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2
Prazo: 1 year post-transplant
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The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated.
Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died.
Assessment of hepatic fibrosis was performed with liver biopsies read centrally.
Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis.
Higher score indicates greater fibrosis.
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1 year post-transplant
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Number of Participants With Fibrosing Cholestatic Hepatitis
Prazo: 1 year post-transplantation
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Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well.
The presence of FCH was reported based on the diagnosis given by the investigator.
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1 year post-transplantation
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Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation
Prazo: 1 year post-transplant
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Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.
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1 year post-transplant
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Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection
Prazo: 1 year post-transplant
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Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy.
BPAR was defined as a treated acute rejection confirmed by biopsy.
The local pathologist graded biopsies according to the Banff (1997) criteria.
A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.
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1 year post-transplant
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Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)
Prazo: 1 year post-transplant
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BPAR was defined as a treated acute rejection confirmed by biopsy.
The local pathologist graded biopsies according to the Banff (1997) criteria.
Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.
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1 year post-transplant
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Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis
Prazo: 1 year post-transplant
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Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.
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1 year post-transplant
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Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)
Prazo: 1 year post-transplant
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Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy.
Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis.
Higher score indicates greater fibrosis.
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1 year post-transplant
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Mean Value of Liver Function Tests at 1 Year Post-transplantation
Prazo: 1 year post-transplant
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The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:
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1 year post-transplant
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Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant
Prazo: Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant
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HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.
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Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant
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Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis
Prazo: Between 1 and 2 years
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Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy.
Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis.
Higher score indicates greater fibrosis.
An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.
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Between 1 and 2 years
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Mean Fibrosis Score
Prazo: At 1and 2 years and its evolution over time
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Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy.
Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis.
Higher score indicates greater fibrosis.
The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).
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At 1and 2 years and its evolution over time
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Processos Patológicos
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças do Fígado
- Infecções por Flaviviridae
- Hepatite, Viral, Humana
- Infecções por Enterovírus
- Infecções por Picornaviridae
- Fibrose
- Hepatite
- Hepatite A
- Hepatite C
- Cirrose hepática
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Inibidores Enzimáticos
- Agentes Antirreumáticos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes dermatológicos
- Antifúngicos
- Inibidores de Calcineurina
- Tacrolimo
- Ciclosporina
- Ciclosporinas
Outros números de identificação do estudo
- COLO400A2426
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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