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

This study is currently recruiting participants.
Verified by Pharmasset, July 2008

Sponsored by: Pharmasset
Information provided by: Pharmasset
ClinicalTrials.gov Identifier: NCT00496158
  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, 72 weeks, and 96 weeks.


Condition Intervention Phase
Chronic Hepatitis
Hepatitis B
Drug: Clevudine
Drug: Adefovir
Phase III

MedlinePlus related topics:   Hepatitis    Hepatitis B   

ChemIDplus related topics:   Hepatitis B Vaccines    Adefovir dipivoxil    Adefovir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study
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 Negative Chronic Hepatitis Due to Hepatitis B Virus

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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496158

Contacts
Contact: clinical.trials@pharmasset.com clinical.trials@pharmasset.com     clinical.trials@pharmasset.com    

Show 27 study locations  Show 27 Study Locations

Sponsors and Collaborators
Pharmasset

Investigators
Study Director:     M Michelle Berrey, MD, MPH     Pharmasset    
  More Information


Study ID Numbers:   CI-PSI-5268-06-306
First Received:   July 2, 2007
Last Updated:   July 9, 2008
ClinicalTrials.gov Identifier:   NCT00496158
Health Authority:   United States: Food and Drug Administration

Keywords provided by Pharmasset:
Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus  
hepatitis b virus  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
Hepatitis, Viral, Human
Adefovir dipivoxil
DNA Virus Infections
Adefovir

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 06, 2008




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