CClinicalTrials.gg
TerminatedNCT00496158QUASH2Updated Apr 27, 2009

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

A Phase 3 interventional study of Clevudine and Adefovir in Chronic Hepatitis and Hepatitis B, sponsored by Pharmasset. Terminated at 119 sites in 11 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by Pharmasset · Phase 3, Interventional, and Treatment

Why this study was terminated
The study was terminated in the interest of patient safety.
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis
  • Hepatitis B

Keywords

  • Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus
  • hepatitis b virus
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

Browse Hepatitis A studies →

Lead sponsor

Pharmasset is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Double

Interventions

  • DrugClevudine
  • DrugAdefovir
06

Study locations

119 sites
  • University of Alabama Birmingham
    Birmingham, Alabama, United States
  • Anaheim, California 92801, United States
  • Advanced Clinical Research Institution
    Anaheim, California, United States
  • Fresno, California 93710, United States
  • Fresno, California, United States
  • West Gastroenterology Medical Group
    Los Angeles, California 90045, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
  • Los Angeles, California, United States
  • 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
  • San Diego, California, United States
  • 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
  • North Miami Beach, Florida 33162, United States
  • Tampa, Florida 33614, United States
  • Infectious Disease Reseach Institute, Inc
    Tampa, Florida, United States
  • 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
  • New Orleans, Louisiana, United States
  • Banks Hepatology Institute
    College Park, Maryland, United States
  • Boston, Massachusetts, United States
  • Digestive Health Specialists
    Tupelo, Mississippi, United States
  • Saint Louis University
    St. Louis, Missouri, United States
  • Hillsborough, New Jersey 08844, United States
  • UMA Research Department
    Binghamton, New York, United States
  • 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
  • New York, New York, United States
  • Asheville, North Carolina 28801, United States
  • Asheville Gastroenterology
    Asheville, North Carolina, United States
  • Duke University
    Durham, North Carolina, United States
  • Cincinnati, Ohio 45242, United States
  • Cincinnati, Ohio, United States
  • Oregon Health & Science University (OHSU)
    Portland, Oregon 97220, United States
  • 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
  • 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
  • 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
  • Salt Lake City, Utah 84121, United States
  • Salt Lake City, Utah, United States
  • University of Virginia
    Charlottesville, Virginia, United States
  • Fairfax, Virginia 22031, United States
  • Metropolitan Research
    Fairfax, Virginia, United States
  • Richmond, Virginia, United States
  • Virginia Mason Medical Center
    Seattle, Washington, United States
  • 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
    Cordoba, 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
  • Vancouver, British Columbia, Canada
  • Halifax, Nova Scotia, Canada
  • St. Joseph's Healthcare
    Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Ottawa, Ontario, Canada
  • 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

Showing the first 100 of 119 sites across 11 countries.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00496158
Lead sponsor
Pharmasset
First posted
Jul 4, 2007
Start date
Aug 2007
Last update
Apr 27, 2009

Study contacts

M Michelle Berrey, MD, MPH
study director · Pharmasset
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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