Registration Studies for New Drug Application (NDA)
The clevudine Phase 3 registration program includes two 48-week clinical trials designed to demonstrate the superiority of clevudine 30mg over Hepsera (adefovir dipivoxil) 10mg, each administered once-daily as monotherapy. Clevudine Study 305 will enroll approximately 376 chronic hepatitis B e-antigen positive patients (HBeAg+), and clevudine Study 306 will enroll approximately 480 chronic hepatitis B e-antigen negative patients (HBeAg-). Pharmasset plans to submit the 48-week data from these studies to the FDA as the basis for clevudine marketing approval.
The primary endpoint for the registration studies is a composite endpoint measuring the proportion of patients with both undetectable serum HBV DNA and normalized liver enzyme (ALT) levels following 48 weeks of monotherapy. The registration studies will also assess improvement in liver histology, hepatitis B e-antigen (eAg) seroconversion, decreases in the reservoir of HBV hepatic cccDNA, and quantitative eAg and surface antigen (sAg). The clevudine registration studies will be conducted in the United States, Canada, Brazil, the United Kingdom, Spain, Greece, Turkey, Romania, Czech Republic, Australia, New Zealand, Singapore, Hong Kong and Taiwan. Please see http://www.clinicaltrials.gov or e-mail email@example.com for more information about the clevudine registration studies.
Assessment of SVR for HBV
After the primary registration data have been obtained at week 48, the
Phase 3 studies will continue to week 96 to gather additional safety and
efficacy data, as well as to assess clevudine's sustained virologic
response (SVR) rate for HBV. SVR is a measure of undet
|SOURCE Pharmasset, Inc.|
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