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A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

12. Februar 2015 aktualisiert von: BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

405

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
      • Adelaide, Australien, 5076
        • Athelstone Medical Clinic
      • Brisbane, Australien
        • Trialworks Clinical Research Services
      • Burwood, Australien
        • Dr Doongs Surgery
      • Darlinghurst, Australien
        • Holdsworth House Medical Practice
      • Melbourne, Australien
        • Doctors of Ivanhoe,
      • Nedlands, Australien
        • Lung Institute of Western Australia,
      • Sydney, Australien
        • Pitt Street Merrylands Medical Centre
    • New South Wales
      • Blacktown, New South Wales, Australien, 2148
        • Pacific Medical Centre Blacktown
      • Darlinghurst, New South Wales, Australien, 2010
        • East Sydney Doctors
      • Hurtsville, New South Wales, Australien, 2220
        • Symbion Pathology
      • Umina, New South Wales, Australien, 2257
        • Peninsula Medical Centre
    • Queensland
      • Auchenflower, Queensland, Australien, 4066
        • Rivercity Private Hospital Specialist
      • Caboolture, Queensland, Australien, 4510
        • Caboolture Clinical Research Centre
      • Kpparing, Queensland, Australien, 4021
        • Peninsula Specialist Centre
    • Victoria
      • Carlton, Victoria, Australien, 3053
        • Health Services -University of Melbourne
  • Neuseeland
      • Auckland, Neuseeland
        • Greenhithe Medical Centre
      • Christchurch, Neuseeland, 4737
        • St George's Hospital
      • Christchurch, Neuseeland
        • Southern Clinical Trials Ltd
      • Dunedin, Neuseeland
        • Caversham Medical Centre
      • Rotorua, Neuseeland, 3010
        • Bairds Road Family Health Care
      • Rotorua, Neuseeland
        • Dr. Gillies
      • Rotorua, Neuseeland
        • Hinemoa House Family Health Centre
  • Südafrika
      • Amanzimtoti, Südafrika, 4126
        • Dr. van Rensburg
      • Benoni, Südafrika, 1501
        • Benmed Park Clinic
      • Bloemfontein, Südafrika, 9301
        • Jsha Research
      • Brits, Südafrika, 0250
        • Armansis Medical Centre
      • Cape Town, Südafrika, 7941
        • First House
      • Cape town, Südafrika, 7490
        • Cape Clinical Trial, Bishop Lavis Day Hospital
      • Durban, Südafrika, 4001
        • Synapta Clinical Research Centre
      • Durban, Südafrika
        • Dr. Janari
      • Johannesburg, Südafrika, 1820
        • Dr. Makan
      • Johannesburg, Südafrika
        • Newgate Centre
      • Port Elizabeth, Südafrika
        • GCT Trials, Mercantile Hospital no 9
      • Pretoria, Südafrika, 0083
        • Dr. Nel
      • Pretoria, Südafrika, 0084
        • Emmed Research
      • Pretoria, Südafrika, 9585
        • Dr. de Bruin
      • Pretoria, Südafrika
        • Westmed Clinical Trial Centre, Pretoria West Medicross Building
      • Roodepoort, Südafrika, 1724
        • Dr. Fouche
      • Scottburgh, Südafrika, 4182
        • Dr. de Villiers
      • Soweto, Südafrika, 1818
        • Dr. Bhorat
      • Worcester, Südafrika, 6850
        • Clinical Projects Research SA Ltd
    • Capetown
      • Goodwood, Capetown, Südafrika, 7460
        • Nortje, MD
    • Durban
      • Greenbury, Durban, Südafrika, 4068
        • Greenbury Medical Centre
      • Silverglen, Durban, Südafrika, 4092
        • Sebastian, MD
    • Free State
      • Bloemfontein, Free State, Südafrika, 9301
        • Quinta-research
    • Gauteg
      • Reigerpark, Gauteg, Südafrika, 1459
        • Wilhase, AC
    • Gauteng
      • Bryanston, Gauteng, Südafrika, 2191
        • NHC Medical Centre
      • Klipspruit West, Gauteng, Südafrika, 1812
        • R. Dulabh, MD
    • KZ-Natal
      • Durban, KZ-Natal, Südafrika, 4091
        • Vawda, Z.FA
    • Krugersdorp
      • Noordheuwel, Krugersdorp, Südafrika, 1739
        • DJW Navorsing
    • Kwa Zulu Natal
      • Verulam, Kwa Zulu Natal, Südafrika, 4340
        • Pillay, MD
    • Pretoria
      • Kempton Park, Pretoria, Südafrika, 1619
        • le Clus, MD
      • Sunnyside Pretoria, Pretoria, Südafrika, 0132
        • Sunnyside Medi-Clinic
    • W. Cape
      • Cape Town, W. Cape, Südafrika, 7500
        • Kaapzicht Centre
      • Cape Town, W. Cape, Südafrika, 7530
        • Syzygy SMO Intercare Medical and Dental Centre
      • Worcester, W. Cape, Südafrika, 6850
        • Clinical Project Research SA (Pty) Ltd.
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35242
        • Greystone Medical Research, LLC
      • Birmingham, Alabama, Vereinigte Staaten, 35209
        • West Alabama Research, Inc.
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85016
        • NextCare Institute For Clinical Research
    • Arkansas
      • Jonesboro, Arkansas, Vereinigte Staaten, 72401
        • NEA Clinic
      • Jonesboro, Arkansas, Vereinigte Staaten, 72401
        • Clopton Clinic
      • Mountain Home, Arkansas, Vereinigte Staaten, 72653
        • North Central Arkansas Medical Associates
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • Impact Clinical Trials
      • Carmichael, California, Vereinigte Staaten, 95608
        • MedCenter
      • Paramount, California, Vereinigte Staaten, 90723
        • Center for Clinical Trials, LLC
      • San Luis Obispo, California, Vereinigte Staaten, 93405
        • Coastal Medical Research Group, Inc.
    • Colorado
      • Boulder, Colorado, Vereinigte Staaten, 80304
        • Alpine Research Center
      • Centennial, Colorado, Vereinigte Staaten, 80112
        • 1st Allergy and Clinical Research Center
    • Florida
      • Coral Gables, Florida, Vereinigte Staaten, 33134
        • Clinical Research of South Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32205
        • Westside Center for Clinical Research
      • Jacksonville, Florida, Vereinigte Staaten, 32216
        • Jacksonville Center for Clinical Research
      • Pembroke Pines, Florida, Vereinigte Staaten, 33024
        • University Clinical Research, Inc.
      • Pinellas Park, Florida, Vereinigte Staaten, 33782
        • DMI Research, Inc.
      • St. Cloud, Florida, Vereinigte Staaten, 34769
        • Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
    • Georgia
      • Columbus, Georgia, Vereinigte Staaten, 31904
        • Southeast Regional Research Group
      • Savannah, Georgia, Vereinigte Staaten, 31406
        • Southeast Regional Research Group
      • Woodstock, Georgia, Vereinigte Staaten, 30188
        • The Kaufmann Clinic, Inc.
    • Idaho
      • Idaho Falls, Idaho, Vereinigte Staaten, 83404
        • Idaho Falls Infectious diseases
    • Illinois
      • Bloomingdale, Illinois, Vereinigte Staaten, 60108
        • Dr. Arthur Davida
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46268
        • Investigators Research Group, Llc
    • Iowa
      • Dubuque, Iowa, Vereinigte Staaten, 52001
        • Medical Associates Clinic
    • Kansas
      • Shawnee, Kansas, Vereinigte Staaten, 66218
        • Heart of America Research
    • Kentucky
      • Hazard, Kentucky, Vereinigte Staaten, 41701
        • Kentucky Lung Clinic
    • Louisiana
      • Baton Rouge, Louisiana, Vereinigte Staaten, 70808
        • Gulf Coast Research, LLC
    • Maine
      • Bangor, Maine, Vereinigte Staaten, 44401
        • Acadia Clinical Research
    • Maryland
      • Clarksburg, Maryland, Vereinigte Staaten, 20871
        • Clarksburg Medical Center
    • Massachusetts
      • Brockton, Massachusetts, Vereinigte Staaten, 02301
        • Miray Medical Center
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48201
        • Detroit Receiving Hospital, UHC 6G
      • Royal Oak, Michigan, Vereinigte Staaten, 48073
        • William Beaumont Hospital
      • St. Claire Shores, Michigan, Vereinigte Staaten, 48081
        • KMED Research
    • Mississippi
      • Olive Branch, Mississippi, Vereinigte Staaten, 38654
        • Olive Branch Family Medical Center
    • Montana
      • Bozeman, Montana, Vereinigte Staaten, 59715
        • Bozeman Urgent Care Center
      • Butte, Montana, Vereinigte Staaten, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Fremont, Nebraska, Vereinigte Staaten, 68025
        • Prairie Fields Family Medicine, P.C.
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89106
        • Impact Clinical Trials, Las Vegas
    • New York
      • Johnson City, New York, Vereinigte Staaten, 13790
        • United Medical Associates
      • Rochester, New York, Vereinigte Staaten, 14618
        • Twelve Corners Internal Medicine
    • North Carolina
      • Greensboro, North Carolina, Vereinigte Staaten, 27401
        • Bland Clinic
    • Ohio
      • Canfield, Ohio, Vereinigte Staaten, 44515
        • Community Medical Associates, LLC
      • Thornville, Ohio, Vereinigte Staaten, 43076
        • Advanced Health Care Services, Inc
    • Oklahoma
      • Owasso, Oklahoma, Vereinigte Staaten, 74055
        • Urgent Care of Green County, PLLC
    • Oregon
      • Ashland, Oregon, Vereinigte Staaten, 97520
        • Integrated Medical Research, PC
    • Pennsylvania
      • Souderton, Pennsylvania, Vereinigte Staaten, 18964
        • Pivotal Clinical Research, Llc
    • Rhode Island
      • Cranston, Rhode Island, Vereinigte Staaten, 02920
        • New England Center for Clinical Research, Inc.
      • Cumberland, Rhode Island, Vereinigte Staaten, 02864
        • Notheast Clinical Research
      • Johnston, Rhode Island, Vereinigte Staaten, 02919
        • Clinical Partners, LLC
      • Warwick, Rhode Island, Vereinigte Staaten, 02886
        • Omega Medical Research
    • South Carolina
      • Simpsonville, South Carolina, Vereinigte Staaten, 29681
        • Hillcrest Clinical Research, LLC
    • South Dakota
      • Rapid City, South Dakota, Vereinigte Staaten, 57702
        • Health Concepts
    • Tennessee
      • Bristol, Tennessee, Vereinigte Staaten, 37620
        • Holston Medical Group
    • Texas
      • Bryan, Texas, Vereinigte Staaten, 77802
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, Vereinigte Staaten, 78414
        • Corpus Christi Family Wellness Center, Research Division
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Allergy/Immunology Research Center of North Texas
      • Garland, Texas, Vereinigte Staaten, 75041
        • Towngate Plaza Medical Center
      • Houston, Texas, Vereinigte Staaten, 77055
        • West Houston Clinical Research
      • San Antonio, Texas, Vereinigte Staaten, 78238
        • Texas Medical Research Associates, LLC
      • Tomball, Texas, Vereinigte Staaten, 77375
        • Martin Diagnostic Clinic
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84088
        • J. Lewis Research, Inc., FirstMed
      • Salt Lake City, Utah, Vereinigte Staaten, 84109
        • J. Lewis Research, Inc./Foothill Family Clinic South
      • Salt Lake City, Utah, Vereinigte Staaten, 84121
        • J. Lewis Research, Inc./FirstMed East
      • Salt Lake City, Utah, Vereinigte Staaten, 84121
        • J. Lewis Research, Inc./Foothill Family Clinic South
    • Washington
      • Bellevue, Washington, Vereinigte Staaten, 98004
        • Northwest Clinical Research Center
    • Wisconsin
      • Oregon, Wisconsin, Vereinigte Staaten, 53575
        • Dean Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥18 years.
  • A positive Influenza A or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one hour.
  • Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
  • Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
  • Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.
  • Onset of symptoms no more than 36 hours before presentation for screening.
  • Written informed consent.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding.
  • Presence of clinically significant signs of acute respiratory distress
  • History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma.
  • History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
  • Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
  • History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).
  • Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
  • Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
  • Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
  • Currently receiving treatment for viral hepatitis B or viral hepatitis C.
  • Presence of known HIV infection with a CD4 count <350 cell/mm3.
  • Current therapy with oral warfarin or other systemic anticoagulant.
  • Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
  • Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
  • Immunized against influenza with inactivated virus vaccine within the previous 14 days.
  • Receipt of any intramuscular injection with the previous 7 days.
  • History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
  • Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
  • Participation in a study of any investigational drug or device within the last 30 days.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Arzneimittel: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Placebo-Komparator: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Arzneimittel: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Zeitfenster: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Influenza Virus Shedding
Zeitfenster: Baseline and Days 3, 4, 9
Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).
Baseline and Days 3, 4, 9

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Subject's Severity of Illness (Score*Hours)
Zeitfenster: Information collected predose on Day 1 and then once daily through Day 14

A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.

The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21.
Information collected predose on Day 1 and then once daily through Day 14
Time to Resolution of Fever
Zeitfenster: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Incidence of Influenza-related Complications
Zeitfenster: 14 days
Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.
14 days
Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)
Zeitfenster: Baseline
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.
Baseline
Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)
Zeitfenster: Baseline and up to 14 days
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.
Baseline and up to 14 days
Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)
Zeitfenster: Baseline and up to 14 days
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Baseline and up to 14 days
Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)
Zeitfenster: Baseline and up to 14 days
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Baseline and up to 14 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

BioCryst Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2008

Primärer Abschluss (Tatsächlich)

1. April 2009

Studienabschluss (Tatsächlich)

1. Oktober 2009

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2008

Zuerst gepostet (Schätzen)

26. Juni 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

16. Februar 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Februar 2015

Zuletzt verifiziert

1. Februar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BCX1812-212
  • HHS 0100200700032C (Andere Zuschuss-/Finanzierungsnummer: HHS-BARDA)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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