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

Phase 3

Terminated

• Conditions: Chronic Hepatitis; Hepatitis B

• Registration Number: NCT00496158
• Lead Sponsor: Pharmasset

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2007-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-23
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (88)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Advanced Clinical Research Institution; 🇺🇸 Anaheim, California, United States

West Gastroenterology Medical Group; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Sharp Rees-Stealy Medical Group, Inc.; 🇺🇸 San Diego, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, 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

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