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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 lutego 2015 zaktualizowane przez: BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

405

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Lek: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Komparator placebo: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Lek: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Influenza Virus Shedding
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Subject's Severity of Illness (Score*Hours)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

BioCryst Pharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2008

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2009

Ukończenie studiów (Rzeczywisty)

1 października 2009

Daty rejestracji na studia

Pierwszy przesłany

24 czerwca 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 czerwca 2008

Pierwszy wysłany (Oszacować)

26 czerwca 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

16 lutego 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lutego 2015

Ostatnia weryfikacja

1 lutego 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BCX1812-212
  • HHS 0100200700032C (Inny numer grantu/finansowania: HHS-BARDA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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