Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

Last updated: April 23, 2009
Sponsor: Pharmasset
Overall Status: Terminated

Phase

3

Condition

Hepatitis C; Chronic

Hepatitis B

Hepatitis

Treatment

N/A

Clinical Study ID

NCT00496002
CI-PSI-5268-06-305
  • Ages > 16
  • All Genders

Study Summary

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 and 96 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant andnon-lactating, aged 16 years or older (or the legal age of consent as allowed by localregulations), with compensated hepatic function despite a diagnosis of chronic HBeAgpositive hepatitis B infection (i.e., based on serological, virological andhistological markers) will be eligible for this study.

  • Subjects with historical biopsies used for entry will have chronic hepaticinflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosisscore ≤ 5). If applicable, subjects must cease previous treatment with any form ofalpha 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 titerand have a creatinine clearance of ≥ 50 mL/min.

Exclusion

Exclusion Criteria:

  • Subjects participating in a clinical trial or receiving an investigational agent forany reason within 60 days of baseline will be excluded.

  • Subjects with clinically significant concomitant diseases will be excluded.

Study Design

Study Start date:
August 01, 2007
Estimated Completion Date:

Connect with a study center

  • Centro De Hepatologia

    Buenos Aires,
    Argentina

    Site Not Available

  • Funcei

    Buenos Aires,
    Argentina

    Site Not Available

  • Fundacion Favaloro

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Aleman

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Universitario Austral

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Guemes

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio de la Trinidad Mitre

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Dei Salvador

    Cordoba,
    Argentina

    Site Not Available

  • H.I.G.A.O. Alende

    Mar del Plata,
    Argentina

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Site Not Available

  • St. Vincent's Health

    Fitzroy, Victoria
    Australia

    Site Not Available

  • Western Hospital

    Footscray, Victoria
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • Fremantle Hospital

    Fremantle, Western Australia
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia
    Australia

    Site Not Available

  • Intituto A.Z.

    Curitiba - PR, PR
    Brazil

    Site Not Available

  • University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital

    Rio de Janeiro, RJ
    Brazil

    Site Not Available

  • Hospital de Clinicas De Porto Alegre - UFRGS

    Porte Alegro, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Facuidade de Medicina do ABC

    Santo Andre, SP
    Brazil

    Site Not Available

  • Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo

    Sao Paulo, SP
    Brazil

    Site Not Available

  • Universidade Federal de Sao Paulo

    Sao Paulo, SP
    Brazil

    Site Not Available

  • PUC-Campinas

    Campinas, Sao Paulo
    Brazil

    Site Not Available

  • School of Medicine of Ribeirao Preto-University of Sao Paulo

    Ribeirao Preto, Sao Paulo
    Brazil

    Site Not Available

  • NICI Infectologia

    Sorocaba, Sao Paulo
    Brazil

    Site Not Available

  • Santa Casa De Belo Horizonte

    Belo Horizonte,
    Brazil

    Site Not Available

  • Instituto de Infectologia Emilio Ribas

    Sao Paulo,
    Brazil

    Site Not Available

  • University of Calgary

    Calgary, Alberta
    Canada

    Site Not Available

  • Liver and Intestinal Research Centre (LAIR Centre)

    Vancouver, British Columbia
    Canada

    Site Not Available

  • UBC/Downtown ID Clinic

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • St. Joseph's Healthcare

    Hamilton, Ontario
    Canada

    Site Not Available

  • London, Ontario
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • The University of Hong Kong

    Pok fu lam, Hong Kong
    China

    Site Not Available

  • The Chinese University of Hong Kong

    Shatin, Hong Kong
    China

    Site Not Available

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po, Hong Kong
    China

    Site Not Available

  • Agios Savvas Hospital

    Athens,
    Greece

    Site Not Available

  • Ippokration General Hospital

    Athens,
    Greece

    Site Not Available

  • Laiko General Hospital

    Athens,
    Greece

    Site Not Available

  • Fundacion de Investigacion de Diego

    Santurce,
    Puerto Rico

    Site Not Available

  • Santurce, 00909
    Puerto Rico

    Site Not Available

  • Hospital General Universitario de Alicant

    Alicante,
    Spain

    Site Not Available

  • Hospital Vall D'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid,
    Spain

    Site Not Available

  • Chang Gung Memorial Hospital Kaosiung

    Kaohsiung,
    Taiwan

    Site Not Available

  • Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital

    Hat Yai, Songkhla
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Siriraj Hosptial, Mahidol University

    Bangkok,
    Thailand

    Site Not Available

  • Chang Mai University

    Chiang Mai,
    Thailand

    Site Not Available

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen,
    Thailand

    Site Not Available

  • Naresuan University

    Phitsanulok,
    Thailand

    Site Not Available

  • Gartnavel General Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • St. George's NHS Trust

    London,
    United Kingdom

    Site Not Available

  • University of Alabama Birmingham

    Birmingham, Alabama
    United States

    Site Not Available

  • Advanced Clinical Research Institution

    Anaheim, California
    United States

    Site Not Available

  • Anaheim, California 92801
    United States

    Site Not Available

  • Fresno, California 93710
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California
    United States

    Site Not Available

  • West Gastroenterology Medical Group

    Los Angeles, California
    United States

    Site Not Available

  • Los Angeles, California 90045
    United States

    Site Not Available

  • San Clemente, California
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego, California
    United States

    Site Not Available

  • Sharp Rees-Stealy Medical Group Inc

    San Diego, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • California Pacific Medical Center

    San Francisco, California
    United States

    Site Not Available

  • Quest Clinical Research

    San Francisco, California 94115
    United States

    Site Not Available

  • Ucsf/Sfgh

    San Francisco, California
    United States

    Site Not Available

  • San Mateo Medical Center

    San Mateo, California
    United States

    Site Not Available

  • The William W. Backus Hospital

    Norwich, Connecticut
    United States

    Site Not Available

  • Norwich, Connecticut 06360
    United States

    Site Not Available

  • Infectious Disease Research Institute, Inc.

    Tampa, Florida
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • Liver Center

    Honolulu, Hawaii
    United States

    Site Not Available

  • Memphis Gastroenterology Group

    Germantown, Indiana
    United States

    Site Not Available

  • Iowa Health-Des Moines

    Des Moines, Iowa
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Banks Hepatology Institute

    College Park, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Digestive Health Specialists

    Tupelo, Mississippi
    United States

    Site Not Available

  • Saint Louis University

    St. Louis, Missouri
    United States

    Site Not Available

  • Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • UMA Research Department

    Binghamton, New York
    United States

    Site Not Available

  • Manhasset, New York
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York
    United States

    Site Not Available

  • VAMC/NYU

    New York, New York
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Asheville Gastroenterology

    Asheville, North Carolina
    United States

    Site Not Available

  • Asheville, North Carolina 28801
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina
    United States

    Site Not Available

  • Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Oregon Heath and Science University (OHSU)

    Portland, Oregon
    United States

    Site Not Available

  • The Oregon Clinica P.C.

    Portland, Oregon
    United States

    Site Not Available

  • Portland, Oregon 97220
    United States

    Site Not Available

  • Nashville Gastrointestinal Specialists, Inc

    Nashville, Tennessee
    United States

    Site Not Available

  • Austin Gastroenterology, PA

    Austin, Texas
    United States

    Site Not Available

  • Austin, Texas 78745
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas
    United States

    Site Not Available

  • Methodist Transplant Physicians

    Dallas, Texas
    United States

    Site Not Available

  • Galveston, Texas
    United States

    Site Not Available

  • Advanced Liver Therapies

    Houston, Texas
    United States

    Site Not Available

  • Century Clinical Research, Inc.

    Houston, Texas
    United States

    Site Not Available

  • Houston, Texas 77028
    United States

    Site Not Available

  • Brooke Army Medical Center

    San Antonio, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia
    United States

    Site Not Available

  • Metropolitan Research

    Fairfax, Virginia
    United States

    Site Not Available

  • Fairfax, Virginia 22031
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington
    United States

    Site Not Available

  • Tacoma, Washington 98405
    United States

    Site Not Available

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