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A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

15 de julho de 2013 atualizado por: Hoffmann-La Roche

A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

Tipo de estudo

Intervencional

Inscrição (Real)

235

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
      • Berlin, Alemanha, 10969
      • Bonn, Alemanha, 53127
      • Düsseldorf, Alemanha, 40225
      • Düsseldorf, Alemanha, 40237
      • Frankfurt Am Main, Alemanha, 60590
      • Freiburg, Alemanha, 79106
      • Giessen, Alemanha, 35392
      • Hamburg, Alemanha, 20099
      • Heidelberg, Alemanha, 69120
      • Jena, Alemanha, 07747
      • Kiel, Alemanha, 24105
      • Köln, Alemanha, 50937
      • Mainz, Alemanha, 55101
      • München, Alemanha, 81675
      • Offenburg, Alemanha, 77654
      • Tübingen, Alemanha, 72076
      • ULM, Alemanha, 89081
  • Austrália
      • Darlinghurst, Austrália, 2010
      • Fremantle, Austrália, 6160
      • Melbourne, Austrália, 3186
      • Nedlands, Austrália, 6009
      • Sydney, Austrália, 2139
  • Brasil
      • Brasilia, Brasil, 70335-000
      • Campinas, Brasil, 13081-970
      • Campinas, Brasil, 13012-970
      • Porto Alegre, Brasil, 90020-090
      • Porto Alegre, Brasil, 90035-003
      • Ribeirao Preto, Brasil, 14049-900
      • Rio de Janeiro, Brasil, 20020-022
      • Santo Andre, Brasil, 09060-650
      • Sao Luis, Brasil, 78048-790
      • Sao Paulo, Brasil, 04040-003
      • Sorocaba, Brasil, 18047-600
      • Vitoria, Brasil, 29043-260
  • Bélgica
      • Antwerpen, Bélgica, 2650
      • Bruxelles, Bélgica, 1020
      • Bruxelles, Bélgica, 1070
      • Bruxelles, Bélgica, 1000
      • Gent, Bélgica, 9000
      • Kortrijk, Bélgica, 8500
      • Liege, Bélgica, 4000
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 2K5
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 4A6
      • Mississauga, Ontario, Canadá, L5M 4N4
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
    • California
      • La Jolla, California, Estados Unidos, 92037-1030
      • Lancaster, California, Estados Unidos, 93534
      • Long Beach, California, Estados Unidos, 90822
      • Los Angeles, California, Estados Unidos, 90048
      • Los Angeles, California, Estados Unidos, 90057
      • Sacramento, California, Estados Unidos, 95817
      • Sacramento, California, Estados Unidos, 95816
      • San Diego, California, Estados Unidos, 92103-8465
      • Torrance, California, Estados Unidos, 90505
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32256
      • Orlando, Florida, Estados Unidos, 32803
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
      • Marietta, Georgia, Estados Unidos, 30060
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70890
      • Opelousas, Louisiana, Estados Unidos, 70520
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
    • Mississippi
      • Tupelo, Mississippi, Estados Unidos, 38801
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
      • St Louis, Missouri, Estados Unidos, 63104
    • New Jersey
      • Egg Harbour Township, New Jersey, Estados Unidos, 08234
      • Hackensack, New Jersey, Estados Unidos, 07601
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87131
    • New York
      • New York, New York, Estados Unidos, 10016
      • Syracuse, New York, Estados Unidos, 13210
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7080
      • Winston-salem, North Carolina, Estados Unidos, 27103
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73112-4481
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
    • Tennessee
      • Kingsport, Tennessee, Estados Unidos, 37660
    • Texas
      • Fort Sam Houston, Texas, Estados Unidos, 78234-3879
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
      • Fairfax, Virginia, Estados Unidos, 22031
      • Richmond, Virginia, Estados Unidos, 23249
  • México
      • Guadalajara, México, 44160
      • Guadalajara, México, 44670
      • Mexicali, México, 21000
      • Mexico City, México, 14050
      • Mexico Df, México, 11649
      • Puebla, México, 72560
  • Porto Rico
      • Santurce, Porto Rico, 00909
  • Suíça
      • Lausanne, Suíça, 1005
      • Lugano, Suíça, 6903
      • St. Gallen, Suíça, 9007
      • Zürich, Suíça, 8091
  • Áustria
      • Graz, Áustria, 8036
      • Innsbruck, Áustria, 6020
      • Linz, Áustria, 4010
      • Oberndorf, Áustria, 5110
      • Wien, Áustria, 1160
      • Wien, Áustria, 1090

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
  • history or other evidence of decompensated liver disease.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PEG-IFN alfa-2a + Ribavirin for 24 weeks
After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
Medicamento: Ribavirina
Outros nomes:
  • Copegus®
Medicamento: peginterferon alfa-2a
Outros nomes:
  • Pegasys®
  • PEG-IFN alfa-2a
Comparador Ativo: PEG-IFN alfa-2a + Ribavirin for 48 weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Medicamento: Ribavirina
Outros nomes:
  • Copegus®
Medicamento: peginterferon alfa-2a
Outros nomes:
  • Pegasys®
  • PEG-IFN alfa-2a

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Prazo: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.

Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
Prazo: 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
24 weeks after actual end of treatment (range from Week 48 to Week 72).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Prazo: Week 72

Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.

Participants without Week 72 measurements were considered non-responders in the analysis.
Week 72
Percentage of Participants With Virological Response at End of Treatment
Prazo: End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Percentage of Participants With Virological Relapse
Prazo: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).

Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.

Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.

Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.
End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
Prazo: 12 weeks after actual end of treatment (range from Week 36 to Week 60)
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
12 weeks after actual end of treatment (range from Week 36 to Week 60)
Number of Participants With Adverse Events (AEs)
Prazo: From Week 1 through Week 72.
An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
From Week 1 through Week 72.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de junho de 2008

Conclusão Primária (Real)

1 de maio de 2012

Conclusão do estudo (Real)

1 de maio de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

18 de fevereiro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de fevereiro de 2008

Primeira postagem (Estimativa)

26 de fevereiro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

22 de julho de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de julho de 2013

Última verificação

1 de julho de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MV21371
  • 2007-004993-15

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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