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

Dong-A ST

Status and phase

Completed

Phase 3

Conditions

Hepatitis B， Chronic

Treatments

Drug: Viread®

Drug: DA-2802

Study type

Interventional

Funder types

Industry

Identifiers

DA2802_HB_III

Details and patient eligibility

About

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

Full description

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

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.