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

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis B; Chronic Hepatitis
• Intervention / Treatment: Drug: Adefovir; Drug: Clevudine

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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 Britanico de Buenos Aires
  • Buenos Aires, Argentina
    • Centro de Hepatologia
  • Cordoba, Argentina
    • Sanatorio Dei Salvador
  • Mar del Plata, Argentina
    • H.I.G.A O. Alende
• Australia
  • New South Wales
    • Concord, New South Wales, Australia
      • Concord Repatriation General Hospital
    • Sydney, New South Wales, Australia
      • Royal Prince Alfred Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • Royal Brisbane and Women'S Hospital
    • Brisbane, Queensland, Australia
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
  • Victoria
    • Fitzroy, Victoria, Australia
      • St. Vincent's
    • Footscray, Victoria, Australia
      • Western Hospital
    • Melbourne, Victoria, Australia
      • Royal Melbourne Hospital
  • Western Australia
    • Fremantle, Western Australia, Australia
      • Fremantle Hospital
    • Perth, Western Australia, Australia
      • 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
• China
  • Hong Kong, China
    • The University of Hong Kong
  • Hong Kong, China
    • The Chinese University of Hong Kong
  • Hong Kong, China
    • Alice Ho Miu Ling Nethersole Hospital
• Greece
  • Athens, Greece
    • Laiko General Hospital
  • Athens, Greece
    • Ippokration General Hospital
  • Athens, Greece
    • Agios Savvas Hospital
• Puerto Rico
  • Santurce, Puerto Rico, 00909
    • Fundacion de Investigacion de Diego
• Spain
  • Alicante, Spain
    • Hospital General Universitario de Alicante
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario de La Princesa
  • Madrid, Spain
    • 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
• United Kingdom
  • Glasgow, United Kingdom
    • Gartnavel General Hospital
  • London, United Kingdom
    • St. George's NHS Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • University of Alabama Birmingham
  • California
    • Anaheim, California, United States, 92801
    • Anaheim, California, United States
      • Advanced Clinical Research Institution
    • Fresno, California, United States
    • Fresno, California, United States, 93710
    • Los Angeles, California, United States
    • Los Angeles, California, United States
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90045
      • West Gastroenterology Medical Group
    • San Clemente, California, United States
    • San Diego, California, United States
    • San Diego, California, United States
      • Medical Associates Research Group
    • San Diego, California, United States, 92123
      • Sharp Rees-Stealy Medical Group, Inc.
    • San Francisco, California, United States, 94115
    • San Francisco, California, United States
      • Quest Clinical Research
    • San Francisco, California, United States
      • California Pacific Medical Center
    • San Francisco, California, United States
      • Ucsf/Sfgh
    • San Mateo, California, United States
      • San Mateo Medical Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • The William W. Backus Hospital
  • Florida
    • North Miami Beach, Florida, United States, 33162
    • Tampa, Florida, United States
    • Tampa, Florida, United States, 33614
    • Tampa, Florida, United States
      • Infectious Disease Reseach Institute, Inc
  • Hawaii
    • Honolulu, Hawaii, United States
      • Liver Center
  • Iowa
    • Des Moines, Iowa, United States
      • Iowa Health-Des Moines
  • Louisiana
    • New Orleans, Louisiana, United States
    • New Orleans, Louisiana, United States
      • Tulane Medical Center
  • Maryland
    • College Park, Maryland, United States
      • Banks Hepatology Institute
  • Massachusetts
    • Boston, Massachusetts, United States
  • Mississippi
    • Tupelo, Mississippi, United States
      • Digestive Health Specialists
  • Missouri
    • St. Louis, Missouri, United States
      • Saint Louis University
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
  • New York
    • Binghamton, New York, United States
      • UMA Research Department
    • Manhasset, New York, United States
    • New York, New York, United States
    • New York, New York, United States
      • Weill Cornell Medical College
    • New York, New York, United States
      • Beth Israel Medical Center
    • New York, New York, United States
      • VAMC/NYU
  • North Carolina
    • Asheville, North Carolina, United States, 28801
    • Asheville, North Carolina, United States
      • Asheville Gastroenterology
    • Durham, North Carolina, United States
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States
    • Cincinnati, Ohio, United States, 45242
  • Oregon
    • Portland, Oregon, United States, 97239
    • Portland, Oregon, United States, 97220
      • Oregon Health & Science University (OHSU)
    • Portland, Oregon, United States
      • The Oregon Clinic P.C.
  • Tennessee
    • Germantown, Tennessee, United States
      • Memphis Gastroenterology Group
    • Nashville, Tennessee, United States
      • Nashville Gastrointestinal Specialists, Inc
  • Texas
    • Austin, Texas, United States, 78745
    • Austin, Texas, United States
      • Austin Gastroenterology, PA
    • Dallas, Texas, United States
      • Baylor University Medical Center
    • Dallas, Texas, United States
      • Methodist Transplant Physicians
    • Galveston, Texas, United States
    • Houston, Texas, United States, 77028
      • Advanced Liver Therapies
    • Houston, Texas, United States
      • Century Clinical Research Inc
    • San Antonio, Texas, United States
      • Brooke Army Mecial Center
  • Utah
    • Salt Lake City, Utah, United States
    • Salt Lake City, Utah, United States, 84121
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia
    • Fairfax, Virginia, United States, 22031
    • Fairfax, Virginia, United States
      • Metropolitan Research
    • Richmond, Virginia, United States
  • Washington
    • Seattle, Washington, United States
      • Virginia Mason Medical Center
    • Tacoma, Washington, United States, 98405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2007

Study Registration Dates

• First Submitted: July 2, 2007
• First Submitted That Met QC Criteria: July 3, 2007
• First Posted (Estimate): July 4, 2007

Study Record Updates

• Last Update Posted (Estimate): April 27, 2009
• Last Update Submitted That Met QC Criteria: April 23, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: hepatitis b virus; Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Adefovir; Clevudine
• Other Study ID Numbers: CI-PSI-5268-06-306