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

This study has been terminated.
(The study was terminated in the interest of patient safety.)
Sponsor:
Information provided by:
Pharmasset
ClinicalTrials.gov Identifier:
NCT00496002
First received: July 2, 2007
Last updated: April 23, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Chronic Hepatitis
Hepatitis B
Drug: Clevudine
Drug: Adefovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pharmasset:

Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496002

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States
United States, California
Advanced Clinical Research Institution
Anaheim, California, United States
Anaheim, California, United States, 92801
Fresno, California, United States
Fresno, California, United States, 93710
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
Medical Associates Research Group
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States, 92123
Sharp Rees-Stealy Medical Group Inc
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Quest Clinical Research
San Francisco, California, United States, 94115
Ucsf/Sfgh
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
Tampa, Florida, United States
Infectious Disease Research Institute, Inc.
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
New Orleans, Louisiana, United States
Tulane Medical Center
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
VAMC/NYU
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
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
The Oregon Clinica P.C.
Portland, Oregon, United States
Oregon Heath and Science University (OHSU)
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
Century Clinical Research, Inc.
Houston, Texas, United States
Houston, Texas, United States, 77028
Advanced Liver Therapies
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
Metropolitan Research
Fairfax, Virginia, United States
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States
Tacoma, Washington, United States, 98405
Argentina
Centro De Hepatologia
Buenos Aires, Argentina
Fundacion Favaloro
Buenos Aires, Argentina
Hospital Aleman
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, Argentina
Funcei
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
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
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra 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
Brazil
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
PUC-Campinas
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
Greece
Agios Savvas Hospital
Athens, Greece
Laiko General Hospital
Athens, Greece
Ippokration General Hospital
Athens, Greece
Puerto Rico
Santurce, Puerto Rico, 00909
Fundacion de Investigacion de Diego
Santurce, Puerto Rico
Spain
Hospital General Universitario de Alicant
Alicante, Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Taiwan
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
Thailand
NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital
Hat Yai, Songkhla, Thailand
Siriraj Hosptial, Mahidol University
Bangkok, Thailand
Phramongkutklao Hospital
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
Pharmasset
Investigators
Study Director: M. Michelle Berrey, MD, MPH Pharmasset
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00496002     History of Changes
Other Study ID Numbers: CI-PSI-5268-06-305
Study First Received: July 2, 2007
Last Updated: April 23, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
2'-fluoro-5-methylarabinosyluracil
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 15, 2014