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

Sponsor
Pharmasset (Industry)
Overall Status
Terminated
CT.gov ID
NCT00496158
Collaborator
(none)
119
Locations

Study Details

Study Description

Brief 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, 72 weeks, and 96 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Birmingham Alabama United States
    2 Anaheim California United States 92801
    3 Advanced Clinical Research Institution Anaheim California United States
    4 Fresno California United States 93710
    5 Fresno California United States
    6 West Gastroenterology Medical Group Los Angeles California United States 90045
    7 Cedars-Sinai Medical Center Los Angeles California United States
    8 Los Angeles California United States
    9 San Clemente California United States
    10 Sharp Rees-Stealy Medical Group, Inc. San Diego California United States 92123
    11 Medical Associates Research Group San Diego California United States
    12 San Diego California United States
    13 San Francisco California United States 94115
    14 California Pacific Medical Center San Francisco California United States
    15 Quest Clinical Research San Francisco California United States
    16 Ucsf/Sfgh San Francisco California United States
    17 San Mateo Medical Center San Mateo California United States
    18 The William W. Backus Hospital Norwich Connecticut United States 06360
    19 North Miami Beach Florida United States 33162
    20 Tampa Florida United States 33614
    21 Infectious Disease Reseach Institute, Inc Tampa Florida United States
    22 Tampa Florida United States
    23 Liver Center Honolulu Hawaii United States
    24 Iowa Health-Des Moines Des Moines Iowa United States
    25 Tulane Medical Center New Orleans Louisiana United States
    26 New Orleans Louisiana United States
    27 Banks Hepatology Institute College Park Maryland United States
    28 Boston Massachusetts United States
    29 Digestive Health Specialists Tupelo Mississippi United States
    30 Saint Louis University St. Louis Missouri United States
    31 Hillsborough New Jersey United States 08844
    32 UMA Research Department Binghamton New York United States
    33 Manhasset New York United States
    34 Beth Israel Medical Center New York New York United States
    35 VAMC/NYU New York New York United States
    36 Weill Cornell Medical College New York New York United States
    37 New York New York United States
    38 Asheville North Carolina United States 28801
    39 Asheville Gastroenterology Asheville North Carolina United States
    40 Duke University Durham North Carolina United States
    41 Cincinnati Ohio United States 45242
    42 Cincinnati Ohio United States
    43 Oregon Health & Science University (OHSU) Portland Oregon United States 97220
    44 Portland Oregon United States 97239
    45 The Oregon Clinic P.C. Portland Oregon United States
    46 Memphis Gastroenterology Group Germantown Tennessee United States
    47 Nashville Gastrointestinal Specialists, Inc Nashville Tennessee United States
    48 Austin Texas United States 78745
    49 Austin Gastroenterology, PA Austin Texas United States
    50 Baylor University Medical Center Dallas Texas United States
    51 Methodist Transplant Physicians Dallas Texas United States
    52 Galveston Texas United States
    53 Advanced Liver Therapies Houston Texas United States 77028
    54 Century Clinical Research Inc Houston Texas United States
    55 Brooke Army Mecial Center San Antonio Texas United States
    56 Salt Lake City Utah United States 84121
    57 Salt Lake City Utah United States
    58 University of Virginia Charlottesville Virginia United States
    59 Fairfax Virginia United States 22031
    60 Metropolitan Research Fairfax Virginia United States
    61 Richmond Virginia United States
    62 Virginia Mason Medical Center Seattle Washington United States
    63 Tacoma Washington United States 98405
    64 Centro de Hepatologia Buenos Aires Argentina
    65 Funcei Buenos Aires Argentina
    66 Fundacion Favaloro Buenos Aires Argentina
    67 Hospital Aleman Buenos Aires Argentina
    68 Hospital Britanico de Buenos Aires Buenos Aires Argentina
    69 Hospital Universitario Austral Buenos Aires Argentina
    70 Sanatorio de la Trinidad Mitre Buenos Aires Argentina
    71 Sanatorio Guemes Buenos Aires Argentina
    72 Sanatorio Dei Salvador Cordoba Argentina
    73 H.I.G.A O. Alende Mar del Plata Argentina
    74 Concord Repatriation General Hospital Concord New South Wales Australia
    75 Royal Prince Alfred Hospital Sydney New South Wales Australia
    76 Princess Alexandra Hospital Brisbane Queensland Australia
    77 Royal Brisbane and Women's Hospital Brisbane Queensland Australia
    78 Royal Adelaide Hospital Adelaide South Australia Australia
    79 St. Vincent's Fitzroy Victoria Australia
    80 Western Hospital Footscray Victoria Australia
    81 Royal Melbourne Hospital Melbourne Victoria Australia
    82 Fremantle Hospital Fremantle Western Australia Australia
    83 Royal Perth Hospital Perth Western Australia Australia
    84 University of Calgary Calgary Alberta Canada
    85 Liver and Intestinal Research Center (LAIR Center) Vancouver British Columbia Canada
    86 UBC/ Downtown ID Clinic Vancouver British Columbia Canada
    87 Vancouver British Columbia Canada
    88 Halifax Nova Scotia Canada
    89 St. Joseph's Healthcare Hamilton Ontario Canada
    90 London Ontario Canada
    91 Ottawa Ontario Canada
    92 Toronto Ontario Canada
    93 Alice Ho Miu Ling Nethersole Hospital Hong Kong China
    94 The Chinese University of Hong Kong Hong Kong China
    95 The University of Hong Kong Hong Kong China
    96 Agios Savvas Hospital Athens Greece
    97 Ippokration General Hospital Athens Greece
    98 Laiko General Hospital Athens Greece
    99 Fundacion de Investigacion de Diego Santurce Puerto Rico 00909
    100 Hospital General Universitario de Alicante Alicante Spain
    101 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    102 Hospital Vall d'Hebron Barcelona Spain
    103 Hospital Clinico San Carlos Madrid Spain
    104 Hospital Universitario de La Princesa Madrid Spain
    105 Hospital Universitario La Paz Madrid Spain
    106 Hospital Universitario Puerta de Hierro Madrid Spain
    107 Chang Gung Memorial Hospital Kaosiung Kaohsiung Taiwan
    108 Kaohsiung Medical University Hospital Kaohsiung Taiwan
    109 Taichung Veterans General Hospital Taichung Taiwan
    110 National Cheng Kung University Hospital Tainan Taiwan
    111 Taipei Veterans General Hospital Taipei Taiwan
    112 NKC Institute of Gastroenterology and Hepatology/ Songklanagarind Hospital Hat Yai Songkhla Thailand
    113 Phramongkutklao Hospital Bangkok Thailand
    114 Siriraj Hospital, Mahidol University Bangkok Thailand
    115 Chiang Mai University Chiang Mai Thailand
    116 Srinagarind Hospital, Khon Kaen University Khon Kaen Thailand
    117 Naresuan University Phitsanulok Thailand
    118 Gartnavel General Hospital Glasgow United Kingdom
    119 St. George's NHS Trust London United Kingdom

    Sponsors and Collaborators

    • Pharmasset

    Investigators

    • Study Director: M Michelle Berrey, MD, MPH, Pharmasset

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00496158
    Other Study ID Numbers:
    • CI-PSI-5268-06-306
    First Posted:
    Jul 4, 2007
    Last Update Posted:
    Apr 27, 2009
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus
    hepatitis b virus
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis
    Hepatitis, Chronic
    Adefovir
    Clevudine

    Study Results

    No Results Posted as of Apr 27, 2009