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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

18 de agosto de 2015 atualizado por: Boehringer Ingelheim

A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

658

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

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá
        • 1220.47.1011 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canadá
        • 1220.47.1012 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canadá
        • 1220.47.1001 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canadá
        • 1220.47.1003 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canadá
        • 1220.47.1016 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canadá
        • 1220.47.1007 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canadá
        • 1220.47.1009 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canadá
        • 1220.47.1013 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canadá
        • 1220.47.1002 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canadá
        • 1220.47.1004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canadá
        • 1220.47.1005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canadá
        • 1220.47.1006 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canadá
        • 1220.47.1015 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá
        • 1220.47.1010 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canadá
        • 1220.47.1014 Boehringer Ingelheim Investigational Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
        • 1220.47.0004 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, Estados Unidos
        • 1220.47.0045 Boehringer Ingelheim Investigational Site
      • Dothan, Alabama, Estados Unidos
        • 1220.47.0050 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, Estados Unidos
        • 1220.47.0061 Boehringer Ingelheim Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Estados Unidos
        • 1220.47.0091 Boehringer Ingelheim Investigational Site
    • California
      • Bakersfield, California, Estados Unidos
        • 1220.47.0008 Boehringer Ingelheim Investigational Site
      • Chula Vista, California, Estados Unidos
        • 1220.47.0019 Boehringer Ingelheim Investigational Site
      • Coronado, California, Estados Unidos
        • 1220.47.0010 Boehringer Ingelheim Investigational Site
      • La Jolla, California, Estados Unidos
        • 1220.47.0033 Boehringer Ingelheim Investigational Site
      • La Mesa, California, Estados Unidos
        • 1220.47.0035 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Estados Unidos
        • 1220.47.0011 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Estados Unidos
        • 1220.47.0014 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Estados Unidos
        • 1220.47.0100 Boehringer Ingelheim Investigational Site
      • Oceanside, California, Estados Unidos
        • 1220.47.0018 Boehringer Ingelheim Investigational Site
      • Poway, California, Estados Unidos
        • 1220.47.0059 Boehringer Ingelheim Investigational Site
      • San Diego, California, Estados Unidos
        • 1220.47.0024 Boehringer Ingelheim Investigational Site
      • San Diego, California, Estados Unidos
        • 1220.47.0037 Boehringer Ingelheim Investigational Site
      • San Francisco, California, Estados Unidos
        • 1220.47.0031 Boehringer Ingelheim Investigational Site
    • Colorado
      • Englewood, Colorado, Estados Unidos
        • 1220.47.0082 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, Estados Unidos
        • 1220.47.0049 Boehringer Ingelheim Investigational Site
    • Florida
      • Bradenton, Florida, Estados Unidos
        • 1220.47.0057 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, Estados Unidos
        • 1220.47.0078 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, Estados Unidos
        • 1220.47.0086 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, Estados Unidos
        • 1220.47.0054 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Estados Unidos
        • 1220.47.0088 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, Estados Unidos
        • 1220.47.0044 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, Estados Unidos
        • 1220.47.0099 Boehringer Ingelheim Investigational Site
      • Palm Harbor, Florida, Estados Unidos
        • 1220.47.0095 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Estados Unidos
        • 1220.47.0074 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos
        • 1220.47.0022 Boehringer Ingelheim Investigational Site
      • Columbus, Georgia, Estados Unidos
        • 1220.47.0039 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, Estados Unidos
        • 1220.47.0052 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos
        • 1220.47.0013 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, Estados Unidos
        • 1220.47.0055 Boehringer Ingelheim Investigational Site
    • Indiana
      • Vaiparaiso, Indiana, Estados Unidos
        • 1220.47.0062 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos
        • 1220.47.0085 Boehringer Ingelheim Investigational Site
      • Baton Rouge, Louisiana, Estados Unidos
        • 1220.47.0087 Boehringer Ingelheim Investigational Site
      • New Orleans, Louisiana, Estados Unidos
        • 1220.47.0101 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, Estados Unidos
        • 1220.47.0064 Boehringer Ingelheim Investigational Site
      • Baltimore, Maryland, Estados Unidos
        • 1220.47.0069 Boehringer Ingelheim Investigational Site
      • Chevy Chase, Maryland, Estados Unidos
        • 1220.47.0067 Boehringer Ingelheim Investigational Site
      • Lutherville, Maryland, Estados Unidos
        • 1220.47.0079 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Framingham, Massachusetts, Estados Unidos
        • 1220.47.0027 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, Estados Unidos
        • 1220.47.0065 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Tulepo, Mississippi, Estados Unidos
        • 1220.47.0023 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos
        • 1220.47.0046 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Neptune, New Jersey, Estados Unidos
        • 1220.47.0066 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, Estados Unidos
        • 1220.47.0097 Boehringer Ingelheim Investigational Site
      • Brooklyn, New York, Estados Unidos
        • 1220.47.0083 Boehringer Ingelheim Investigational Site
      • New York, New York, Estados Unidos
        • 1220.47.0003 Boehringer Ingelheim Investigational Site
      • New York, New York, Estados Unidos
        • 1220.47.0006 Boehringer Ingelheim Investigational Site
      • New York, New York, Estados Unidos
        • 1220.47.0038 Boehringer Ingelheim Investigational Site
      • New York, New York, Estados Unidos
        • 1220.47.0090 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos
        • 1220.47.0053 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, Estados Unidos
        • 1220.47.0021 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos
        • 1220.47.0098 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, Estados Unidos
        • 1220.47.0028 Boehringer Ingelheim Investigational Site
      • Portland, Oregon, Estados Unidos
        • 1220.47.0058 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Germantown, Tennessee, Estados Unidos
        • 1220.47.0030 Boehringer Ingelheim Investigational Site
      • Jackson, Tennessee, Estados Unidos
        • 1220.47.0072 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, Estados Unidos
        • 1220.47.0032 Boehringer Ingelheim Investigational Site
      • Nashville, Tennessee, Estados Unidos
        • 1220.47.0041 Boehringer Ingelheim Investigational Site
    • Texas
      • Arlington, Texas, Estados Unidos
        • 1220.47.0063 Boehringer Ingelheim Investigational Site
      • Austin, Texas, Estados Unidos
        • 1220.47.0029 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Estados Unidos
        • 1220.47.0017 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Estados Unidos
        • 1220.47.0056 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Estados Unidos
        • 1220.47.0071 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, Estados Unidos
        • 1220.47.0060 Boehringer Ingelheim Investigational Site
      • Forth Worth, Texas, Estados Unidos
        • 1220.47.0081 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1220.47.0009 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Estados Unidos
        • 1220.47.0068 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, Estados Unidos
        • 1220.47.0016 Boehringer Ingelheim Investigational Site
    • Vermont
      • Burlington, Vermont, Estados Unidos
        • 1220.47.0015 Boehringer Ingelheim Investigational Site
    • Virginia
      • Annandale, Virginia, Estados Unidos
        • 1220.47.0042 Boehringer Ingelheim Investigational Site
      • Falls Church, Virginia, Estados Unidos
        • 1220.47.0043 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, Estados Unidos
        • 1220.47.0026 Boehringer Ingelheim Investigational Site
    • Washington
      • Seattle, Washington, Estados Unidos
        • 1220.47.0092 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos
        • 1220.47.0073 Boehringer Ingelheim Investigational Site
  • Porto Rico
      • San Juan, Porto Rico
        • 1220.47.0034 Boehringer Ingelheim Investigational Site
  • Republica da Coréia
      • Pusan, Republica da Coréia
        • 1220.47.8204 Boehringer Ingelheim Investigational Site
      • Pusan, Republica da Coréia
        • 1220.47.8205 Boehringer Ingelheim Investigational Site
      • Seongnam, Republica da Coréia
        • 1220.47.8203 Boehringer Ingelheim Investigational Site
      • Seoul, Republica da Coréia
        • 1220.47.8202 Boehringer Ingelheim Investigational Site
      • Seoul, Republica da Coréia
        • 1220.47.8206 Boehringer Ingelheim Investigational Site
      • Seoul, Republica da Coréia
        • 1220.47.8207 Boehringer Ingelheim Investigational Site
      • Yangsan, Republica da Coréia
        • 1220.47.8201 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 1220.47.8803 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1220.47.8804 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1220.47.8802 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1220.47.8801 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1220.47.8805 Boehringer Ingelheim Investigational Site

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 a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:

    1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
    2. liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening.
  3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
  4. HCV RNA = 1,000 IU/mL at screening

  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit.

    Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.

  6. Age 18 to 70 years

  7. Female patients:

    (c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.

    Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.

    Male patients:

    1. who are documented to be sterile, or
    2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase.
  8. Signed informed consent form prior to trial participation

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
  3. HIV co-infection.
  4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
  5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
  7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study.
  8. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
  9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
  10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
  11. Known hypersensitivity to any ingredient of the study drugs.
  12. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).

  13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:

    1. International normalized ratio (INR) of =1.7
    2. Serum Albumin =3.5 g/dL
    3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
  14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Medicamento: Placebo
Comparador Ativo: PegIFN/RBV
48 weeks
Medicamento: PegIFN/RBV
Experimental: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Medicamento: PegIFN/RBV
Medicamento: BI201335
QD BI 201335
Medicamento: BI201335
QD (once daily) BI 201335
Experimental: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Medicamento: PegIFN/RBV
Medicamento: BI201335
QD BI 201335
Medicamento: BI201335
QD (once daily) BI 201335

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Prazo: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
12 weeks post treatment, up to 60 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Prazo: 24 weeks post treatment, up to 72 weeks

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Hepatitis C virus Ribonucleic acid (HCV RNA)
24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Prazo: Week 4 and week 8
Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
Week 4 and week 8
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Prazo: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks post treatment, up to 60 weeks

Colaboradores e Investigadores

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

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

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 abril de 2011

Conclusão Primária (Real)

1 de abril de 2014

Conclusão do estudo (Real)

1 de abril de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

15 de fevereiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de fevereiro de 2011

Primeira postagem (Estimativa)

16 de fevereiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de setembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2015

Última verificação

1 de agosto de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1220.47
  • 2010-021716-42 (Número EudraCT: EudraCT)

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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