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Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus (QUASH2)

23. april 2009 opdateret af: Pharmasset

A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Argentina
- - Buenos Aires, Argentina
    - Hospital Aleman
  - Buenos Aires, Argentina
    - Sanatorio Güemes
  - Buenos Aires, Argentina
    - FUNCEI
  - Buenos Aires, Argentina
    - Hospital Universitario Austral
  - Buenos Aires, Argentina
    - Fundacion Favaloro
  - Buenos Aires, Argentina
    - Sanatorio de la Trinidad Mitre
  - Buenos Aires, Argentina
    - Hospital Británico de Buenos Aires
  - Buenos Aires, Argentina
    - Centro de Hepatologia
  - Cordoba, Argentina
    - Sanatorio Dei Salvador
  - Mar del Plata, Argentina
    - H.I.G.A O. Alende
Australien
- New South Wales
  - Concord, New South Wales, Australien
    - Concord Repatriation General Hospital
  - Sydney, New South Wales, Australien
    - Royal Prince Alfred Hospital
- Queensland
  - Brisbane, Queensland, Australien
    - Royal Brisbane and Women's Hospital
  - Brisbane, Queensland, Australien
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australien
    - Royal Adelaide Hospital
- Victoria
  - Fitzroy, Victoria, Australien
    - St. Vincent's
  - Footscray, Victoria, Australien
    - Western Hospital
  - Melbourne, Victoria, Australien
    - Royal Melbourne Hospital
- Western Australia
  - Fremantle, Western Australia, Australien
    - Fremantle Hospital
  - Perth, Western Australia, Australien
    - Royal Perth Hospital
Canada
- Alberta
  - Calgary, Alberta, Canada
    - University Of Calgary
- British Columbia
  - Vancouver, British Columbia, Canada
  - Vancouver, British Columbia, Canada
    - Liver and Intestinal Research Center (LAIR Center)
  - Vancouver, British Columbia, Canada
    - UBC/ Downtown ID Clinic
- Nova Scotia
  - Halifax, Nova Scotia, Canada
- Ontario
  - Hamilton, Ontario, Canada
    - St. Joseph's Healthcare
  - London, Ontario, Canada
  - Ottawa, Ontario, Canada
  - Toronto, Ontario, Canada
Det Forenede Kongerige
- - Glasgow, Det Forenede Kongerige
    - Gartnavel General Hospital
  - London, Det Forenede Kongerige
    - St. George's NHS Trust
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater
    - University of Alabama Birmingham
- California
  - Anaheim, California, Forenede Stater, 92801
  - Anaheim, California, Forenede Stater
    - Advanced Clinical Research Institution
  - Fresno, California, Forenede Stater
  - Fresno, California, Forenede Stater, 93710
  - Los Angeles, California, Forenede Stater
  - Los Angeles, California, Forenede Stater
    - Cedars-Sinai Medical Center
  - Los Angeles, California, Forenede Stater, 90045
    - West Gastroenterology Medical Group
  - San Clemente, California, Forenede Stater
  - San Diego, California, Forenede Stater
  - San Diego, California, Forenede Stater
    - Medical Associates Research Group
  - San Diego, California, Forenede Stater, 92123
    - Sharp Rees-Stealy Medical Group, Inc.
  - San Francisco, California, Forenede Stater, 94115
  - San Francisco, California, Forenede Stater
    - Quest Clinical Research
  - San Francisco, California, Forenede Stater
    - California Pacific Medical Center
  - San Francisco, California, Forenede Stater
    - Ucsf/Sfgh
  - San Mateo, California, Forenede Stater
    - San Mateo Medical Center
- Connecticut
  - Norwich, Connecticut, Forenede Stater, 06360
    - The William W. Backus Hospital
- Florida
  - North Miami Beach, Florida, Forenede Stater, 33162
  - Tampa, Florida, Forenede Stater
  - Tampa, Florida, Forenede Stater, 33614
  - Tampa, Florida, Forenede Stater
    - Infectious Disease Reseach Institute, Inc
- Hawaii
  - Honolulu, Hawaii, Forenede Stater
    - Liver Center
- Iowa
  - Des Moines, Iowa, Forenede Stater
    - Iowa Health-Des Moines
- Louisiana
  - New Orleans, Louisiana, Forenede Stater
  - New Orleans, Louisiana, Forenede Stater
    - Tulane Medical Center
- Maryland
  - College Park, Maryland, Forenede Stater
    - Banks Hepatology Institute
- Massachusetts
  - Boston, Massachusetts, Forenede Stater
- Mississippi
  - Tupelo, Mississippi, Forenede Stater
    - Digestive Health Specialists
- Missouri
  - St. Louis, Missouri, Forenede Stater
    - Saint Louis University
- New Jersey
  - Hillsborough, New Jersey, Forenede Stater, 08844
- New York
  - Binghamton, New York, Forenede Stater
    - UMA Research Department
  - Manhasset, New York, Forenede Stater
  - New York, New York, Forenede Stater
  - New York, New York, Forenede Stater
    - Weill Cornell Medical College
  - New York, New York, Forenede Stater
    - Beth Israel Medical Center
  - New York, New York, Forenede Stater
    - VAMC/NYU
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
  - Asheville, North Carolina, Forenede Stater
    - Asheville Gastroenterology
  - Durham, North Carolina, Forenede Stater
    - Duke University
- Ohio
  - Cincinnati, Ohio, Forenede Stater
  - Cincinnati, Ohio, Forenede Stater, 45242
- Oregon
  - Portland, Oregon, Forenede Stater, 97239
  - Portland, Oregon, Forenede Stater, 97220
    - Oregon Health & Science University (OHSU)
  - Portland, Oregon, Forenede Stater
    - The Oregon Clinic P.C.
- Tennessee
  - Germantown, Tennessee, Forenede Stater
    - Memphis Gastroenterology Group
  - Nashville, Tennessee, Forenede Stater
    - Nashville Gastrointestinal Specialists, Inc
- Texas
  - Austin, Texas, Forenede Stater, 78745
  - Austin, Texas, Forenede Stater
    - Austin Gastroenterology, PA
  - Dallas, Texas, Forenede Stater
    - Baylor University Medical Center
  - Dallas, Texas, Forenede Stater
    - Methodist Transplant Physicians
  - Galveston, Texas, Forenede Stater
  - Houston, Texas, Forenede Stater, 77028
    - Advanced Liver Therapies
  - Houston, Texas, Forenede Stater
    - Century Clinical Research Inc
  - San Antonio, Texas, Forenede Stater
    - Brooke Army Mecial Center
- Utah
  - Salt Lake City, Utah, Forenede Stater
  - Salt Lake City, Utah, Forenede Stater, 84121
- Virginia
  - Charlottesville, Virginia, Forenede Stater
    - University of Virginia
  - Fairfax, Virginia, Forenede Stater, 22031
  - Fairfax, Virginia, Forenede Stater
    - Metropolitan Research
  - Richmond, Virginia, Forenede Stater
- Washington
  - Seattle, Washington, Forenede Stater
    - Virginia Mason Medical Center
  - Tacoma, Washington, Forenede Stater, 98405
Grækenland
- - Athens, Grækenland
    - Laiko General Hospital
  - Athens, Grækenland
    - Ippokration General Hospital
  - Athens, Grækenland
    - Agios Savvas Hospital
Kina
- - Hong Kong, Kina
    - The University of Hong Kong
  - Hong Kong, Kina
    - The Chinese University of Hong Kong
  - Hong Kong, Kina
    - Alice Ho Miu Ling Nethersole Hospital
Puerto Rico
- - Santurce, Puerto Rico, 00909
    - Fundacion De Investigacion de Diego
Spanien
- - Alicante, Spanien
    - Hospital General Universitario de Alicante
  - Barcelona, Spanien
    - Hospital de La Santa Creu i Sant Pau
  - Barcelona, Spanien
    - Hospital Vall d'hebrón
  - Madrid, Spanien
    - Hospital Clinico San Carlos
  - Madrid, Spanien
    - Hospital Universitario La Paz
  - Madrid, Spanien
    - Hospital Universitario de La Princesa
  - Madrid, Spanien
    - Hospital Universitario Puerta De Hierro
Taiwan
- - Kaohsiung, Taiwan
    - Kaohsiung Medical University Hospital
  - Kaohsiung, Taiwan
    - Chang Gung Memorial Hospital Kaosiung
  - Taichung, Taiwan
    - Taichung Veterans General Hospital
  - Tainan, Taiwan
    - National Cheng Kung University Hospital
  - Taipei, Taiwan
    - Taipei Veterans General Hospital
Thailand
- - Bangkok, Thailand
    - Phramongkutklao Hospital
  - Bangkok, Thailand
    - Siriraj Hospital, Mahidol University
  - Chiang Mai, Thailand
    - Chiang Mai University
  - Khon Kaen, Thailand
    - Srinagarind Hospital, Khon Kaen University
  - Phitsanulok, Thailand
    - Naresuan University
- Songkhla
  - Hat Yai, Songkhla, Thailand
    - NKC Institute of Gastroenterology and Hepatology/ Songklanagarind Hospital

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg negative hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
Subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5).
The number of subjects entering the study with an Ishak fibrosis score of 5 will be limited to approximately 10%. If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.

Exclusion Criteria:

Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
Subjects with clinically significant concomitant diseases will be excluded.

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
Maskning: Dobbelt

Samarbejdspartnere og efterforskere

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

Sponsor

Pharmasset

Efterforskere

Studieleder: M Michelle Berrey, MD, MPH, Pharmasset

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. august 2007

Datoer for studieregistrering

Først indsendt

2. juli 2007

Først indsendt, der opfyldte QC-kriterier

3. juli 2007

Først opslået (Skøn)

4. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. april 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2009

Sidst verificeret

1. april 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CI-PSI-5268-06-306

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 .