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

Phase 3

Completed

• Conditions: Hepatitis B， Chronic
• Interventions: Drug: Viread®; Drug: DA-2802

• Registration Number: NCT02967939
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Study Start: 2017-03-28
• Primary Completion: 2019-01-23
• Study Completion: 2019-07-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viread®	Viread®	Viread® 300mg tablet qd
DA-2802	DA-2802	DA-2802 319mg tablet qd

Primary Outcome Measures

Name	Time	Method
Difference of HBV DNA level(log10)	Change from baseline at 48 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects who experienced loss of HBeAg	at 24 week, 48 week
Percentage of subjects HBV DNA < 400 copies/ml	at 24 weeks, 48 weeks
Percentage of subjects who had normal ALT levels	at 24 week, 48 week

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of