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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 agosto 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

658

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Comparatore attivo: PegIFN/RBV
48 weeks
Droga: PegIFN/RBV
Sperimentale: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Droga: PegIFN/RBV
Droga: BI201335
QD BI 201335
Droga: BI201335
QD (once daily) BI 201335
Sperimentale: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Droga: PegIFN/RBV
Droga: BI201335
QD BI 201335
Droga: BI201335
QD (once daily) BI 201335

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2011

Completamento primario (Effettivo)

1 aprile 2014

Completamento dello studio (Effettivo)

1 aprile 2014

Date di iscrizione allo studio

Primo inviato

15 febbraio 2011

Primo inviato che soddisfa i criteri di controllo qualità

15 febbraio 2011

Primo Inserito (Stima)

16 febbraio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 settembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2015

Ultimo verificato

1 agosto 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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