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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. srpna 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

658

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Lék: Placebo
Aktivní komparátor: PegIFN/RBV
48 weeks
Lék: PegIFN/RBV
Experimentální: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Lék: PegIFN/RBV
Lék: BI201335
QD BI 201335
Lék: BI201335
QD (once daily) BI 201335
Experimentální: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Lék: PegIFN/RBV
Lék: BI201335
QD BI 201335
Lék: BI201335
QD (once daily) BI 201335

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2011

Primární dokončení (Aktuální)

1. dubna 2014

Dokončení studie (Aktuální)

1. dubna 2014

Termíny zápisu do studia

První předloženo

15. února 2011

První předloženo, které splnilo kritéria kontroly kvality

15. února 2011

První zveřejněno (Odhad)

16. února 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

18. září 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. srpna 2015

Naposledy ověřeno

1. srpna 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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