Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus (QUASH 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496002
Recruitment Status : Terminated (The study was terminated in the interest of patient safety.)
First Posted : July 4, 2007
Last Update Posted : April 27, 2009
Information provided by:

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 and 96 weeks.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis Hepatitis B Drug: Clevudine Drug: Adefovir Phase 3

Study Type : Interventional  (Clinical Trial)
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 Positive Chronic Hepatitis Due to Hepatitis B Virus
Study Start Date : August 2007

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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 positive hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
  • Subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5). 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496002

  Hide Study Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States
United States, California
Anaheim, California, United States, 92801
Advanced Clinical Research Institution
Anaheim, California, United States
Fresno, California, United States, 93710
Fresno, California, United States
Los Angeles, California, United States, 90045
Cedars-Sinai Medical Center
Los Angeles, California, United States
West Gastroenterology Medical Group
Los Angeles, California, United States
Los Angeles, California, United States
San Clemente, California, United States
San Diego, California, United States, 92123
Medical Associates Research Group
San Diego, California, United States
Sharp Rees-Stealy Medical Group Inc
San Diego, California, United States
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States, 94115
California Pacific Medical Center
San Francisco, California, United States
San Francisco, California, United States
San Mateo Medical Center
San Mateo, California, United States
United States, Connecticut
Norwich, Connecticut, United States, 06360
The William W. Backus Hospital
Norwich, Connecticut, United States
United States, Florida
Tampa, Florida, United States, 33614
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States
Tampa, Florida, United States
United States, Hawaii
Liver Center
Honolulu, Hawaii, United States
United States, Indiana
Memphis Gastroenterology Group
Germantown, Indiana, United States
United States, Iowa
Iowa Health-Des Moines
Des Moines, Iowa, United States
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Banks Hepatology Institute
College Park, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Mississippi
Digestive Health Specialists
Tupelo, Mississippi, United States
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
United States, New York
UMA Research Department
Binghamton, New York, United States
Manhasset, New York, United States
Beth Israel Medical Center
New York, New York, United States
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States, 28801
Asheville Gastroenterology
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cincinnati, Ohio, United States
United States, Oregon
Portland, Oregon, United States, 97220
Portland, Oregon, United States, 97239
Oregon Heath and Science University (OHSU)
Portland, Oregon, United States
The Oregon Clinica P.C.
Portland, Oregon, United States
United States, Tennessee
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States, 78745
Austin Gastroenterology, PA
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Methodist Transplant Physicians
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States, 77028
Advanced Liver Therapies
Houston, Texas, United States
Century Clinical Research, Inc.
Houston, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States, 84121
Salt Lake City, Utah, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Fairfax, Virginia, United States, 22031
Metropolitan Research
Fairfax, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States
Tacoma, Washington, United States, 98405
Centro De Hepatologia
Buenos Aires, Argentina
Buenos Aires, Argentina
Fundacion Favaloro
Buenos Aires, Argentina
Hospital Aleman
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, Argentina
Sanatorio Guemes
Buenos Aires, Argentina
Sanatorio Dei Salvador
Cordoba, Argentina
H.I.G.A.O. Alende
Mar del Plata, Argentina
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
St. Vincent's Health
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Intituto A.Z.
Curitiba - PR, PR, Brazil
Hospital de Clinicas De Porto Alegre - UFRGS
Porte Alegro, Rio Grande Do Sul, Brazil
University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital
Rio de Janeiro, RJ, Brazil
Campinas, Sao Paulo, Brazil
School of Medicine of Ribeirao Preto-University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil
NICI Infectologia
Sorocaba, Sao Paulo, Brazil
Facuidade de Medicina do ABC
Santo Andre, SP, Brazil
Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo
Sao Paulo, SP, Brazil
Universidade Federal de Sao Paulo
Sao Paulo, SP, Brazil
Santa Casa De Belo Horizonte
Belo Horizonte, Brazil
Instituto de Infectologia Emilio Ribas
Sao Paulo, Brazil
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Canada, British Columbia
Liver and Intestinal Research Centre (LAIR Centre)
Vancouver, British Columbia, Canada
UBC/Downtown ID Clinic
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
China, Hong Kong
The University of Hong Kong
Pok fu lam, Hong Kong, China
The Chinese University of Hong Kong
Shatin, Hong Kong, China
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong, China
Agios Savvas Hospital
Athens, Greece
Ippokration General Hospital
Athens, Greece
Laiko General Hospital
Athens, Greece
Puerto Rico
Santurce, Puerto Rico, 00909
Fundacion de Investigacion de Diego
Santurce, Puerto Rico
Hospital General Universitario de Alicant
Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Chang Gung Memorial Hospital Kaosiung
Kaohsiung, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital
Hat Yai, Songkhla, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Siriraj Hosptial, Mahidol University
Bangkok, Thailand
Chang Mai University
Chiang Mai, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand
Naresuan University
Phitsanulok, Thailand
United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
St. George's NHS Trust
London, United Kingdom
Sponsors and Collaborators
Study Director: M. Michelle Berrey, MD, MPH Pharmasset Identifier: NCT00496002     History of Changes
Other Study ID Numbers: CI-PSI-5268-06-305
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by Pharmasset:
Hepatitis B virus
Nucleoside Treatment-Naïve Patients with HBeAg Positive

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents