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

Stopped early · Phase 3

Conditions studied: Chronic Hepatitis, Hepatitis B

In brief

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.

Key facts

Study ID

NCT00496158

Run by

Pharmasset

Starts

2007-08-01

Last updated by the study team

2009-04-27

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Anaheim, California, United States
• Advanced Clinical Research Institution — Anaheim, California, United States
• Study site — Fresno, California, United States
• Study site — Fresno, California, United States
• West Gastroenterology Medical Group — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Clemente, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, 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
• The William W. Backus Hospital — Norwich, Connecticut, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Tampa, Florida, United States
• Infectious Disease Reseach Institute, Inc — Tampa, Florida, United States
• Study site — 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
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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