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

July 2, 2007
April 23, 2009
August 2007
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Complete list of historical versions of study NCT00496002 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Chronic Hepatitis
  • Hepatitis B
  • Drug: Clevudine
  • Drug: Adefovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico,   Greece,   China,   Argentina,   Taiwan,   Thailand,   Australia,   Brazil,   United Kingdom,   Spain
 
NCT00496002
CI-PSI-5268-06-305
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Pharmasset
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Study Director: M. Michelle Berrey, MD, MPH Pharmasset
Pharmasset
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP