Study Stopped
The study was terminated in the interest of patient safety.
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
1 other identifier
interventional
N/A
11 countries
119
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedApril 27, 2009
April 1, 2009
July 2, 2007
April 23, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmassetlead
Study Sites (119)
University of Alabama Birmingham
Birmingham, Alabama, United States
Unknown Facility
Anaheim, California, 92801, United States
Advanced Clinical Research Institution
Anaheim, California, United States
Unknown Facility
Fresno, California, 93710, United States
Unknown Facility
Fresno, California, United States
West Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Clemente, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92123, United States
Medical Associates Research Group
San Diego, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, 94115, United States
California Pacific Medical Center
San Francisco, California, United States
Quest Clinical Research
San Francisco, California, United States
Ucsf/Sfgh
San Francisco, California, United States
San Mateo Medical Center
San Mateo, California, United States
The William W. Backus Hospital
Norwich, Connecticut, 06360, United States
Unknown Facility
North Miami Beach, Florida, 33162, United States
Unknown Facility
Tampa, Florida, 33614, United States
Infectious Disease Reseach Institute, Inc
Tampa, Florida, United States
Unknown Facility
Tampa, Florida, United States
Liver Center
Honolulu, Hawaii, United States
Iowa Health-Des Moines
Des Moines, Iowa, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Banks Hepatology Institute
College Park, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Digestive Health Specialists
Tupelo, Mississippi, United States
Saint Louis University
St Louis, Missouri, United States
Unknown Facility
Hillsborough, New Jersey, 08844, United States
UMA Research Department
Binghamton, New York, United States
Unknown Facility
Manhasset, New York, United States
Beth Israel Medical Center
New York, New York, United States
VAMC/NYU
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Asheville Gastroenterology
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97220, United States
Unknown Facility
Portland, Oregon, 97239, United States
The Oregon Clinic P.C.
Portland, Oregon, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, 78745, United States
Austin Gastroenterology, PA
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Methodist Transplant Physicians
Dallas, Texas, United States
Unknown Facility
Galveston, Texas, United States
Advanced Liver Therapies
Houston, Texas, 77028, United States
Century Clinical Research Inc
Houston, Texas, United States
Brooke Army Mecial Center
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Metropolitan Research
Fairfax, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Centro de Hepatologia
Buenos Aires, Argentina
Funcei
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
Córdoba, Argentina
H.I.G.A O. Alende
Mar del Plata, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
St. Vincent's
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
Liver and Intestinal Research Center (LAIR Center)
Vancouver, British Columbia, Canada
UBC/ Downtown ID Clinic
Vancouver, British Columbia, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, China
The Chinese University of Hong Kong
Hong Kong, China
The University of Hong Kong
Hong Kong, China
Agios Savvas Hospital
Athens, Greece
Ippokration General Hospital
Athens, Greece
Laiko General Hospital
Athens, Greece
Fundacion de Investigacion de Diego
Santurce, 00909, Puerto Rico
Hospital General Universitario de Alicante
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 City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 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, Changwat Songkhla, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand
Naresuan University
Phitsanulok, Thailand
Gartnavel General Hospital
Glasgow, United Kingdom
St. George's NHS Trust
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
M Michelle Berrey, MD, MPH
Pharmasset
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 4, 2007
Study Start
August 1, 2007
Last Updated
April 27, 2009
Record last verified: 2009-04