Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients

Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients

A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients

1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.

Inclusion Criteria:

• Patients with chronic hepatitis B aged 18 years or older
• Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit
• Subjects who have HBsAg positive test at screening visit
• Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test
• Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening

Exclusion Criteria:

• Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus

• Subjects with creatinine clearance of less than 50 ml/min at the screening visit

• At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma

• Subjects with decompensated liver disease who meet the following criteria:

  1. Total bilirubin levels greater than 2.5 mg/dl
  2. Prothrombin time is at least 3 seconds longer than normal upper limit
  3. Serum albumin value less than 30 g/l
  4. Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.