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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967939
• Other study ID #: DA2802_HB_III
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: April 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 15, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• DA-2802
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
• Viread®
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of HBV DNA level(log10)		Change from baseline at 48 weeks
Secondary	Percentage of subjects HBV DNA < 400 copies/ml		at 24 weeks, 48 weeks
Secondary	Percentage of subjects who had normal ALT levels		at 24 week, 48 week
Secondary	Percentage of subjects who experienced loss of HBeAg		at 24 week, 48 week