Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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. august 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

658

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Aktiv komparator: PegIFN/RBV
48 weeks
Medicin: PegIFN/RBV
Eksperimentel: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Medicin: PegIFN/RBV
Medicin: BI201335
QD BI 201335
Medicin: BI201335
QD (once daily) BI 201335
Eksperimentel: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Medicin: PegIFN/RBV
Medicin: BI201335
QD BI 201335
Medicin: BI201335
QD (once daily) BI 201335

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

15. februar 2011

Først indsendt, der opfyldte QC-kriterier

15. februar 2011

Først opslået (Skøn)

16. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner