Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection.

Condition	Treatment or Intervention	Phase
Chronic Hepatitis B	Drug: telbivudine or lamivudine	Phase III

Ages Eligible for Study:  16 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Chronic Hepatitis B, documented by: Clinical history compatible with chronic HBV, Positive serum HBsAg, HBeAg-positive OR HBeAg-negative, Liver biopsy pre-treatment consistent with chronic HBV
• Elevated serum ALT at (> or =1.3–10xULN)
• Serum HBV DNA > or =6 log10 copies/mL
• Patient willing and able to comply with the study drug regimen and all other study requirements
• Patient or guardian has provided written informed consent

Exclusion Criteria:

• Patient is pregnant or breastfeeding
• Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b-HCG) at Screen
• Patient is of childbearing potential and unwilling to use a barrier method of contraception
• Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2. Patients will be tested for antibodies to HCV, HIV, and HDV in the screening assessments performed at the central laboratory
• Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
• Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
• Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc)
• Patient has a history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of hepatic decompensation
• Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
• Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years
• Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids
• Patient has a medical condition requiring the use of potentially hepatotoxic drugs
• Patients who has been on warfarin or other anticoagulants during 30 days prior to screening or if expected during the present study
• Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B

Barbara Fielman, RN, MS, PNP      617-995-9812    fielman.barbara@idenix.com

California
      Dr. Tuan Research and Education, Inc., San Diego,  California,  92115,  United States; Recruiting

Study ID Numbers:  NV-02B-007
Record last reviewed:  January 2004
Record first received:  March 28, 2003
ClinicalTrials.gov Identifier:  NCT00057265
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10