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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2019-07-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatitis B， Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-2802

DA-2802 319mg tablet qd

Group Type EXPERIMENTAL

DA-2802

Intervention Type DRUG

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

Viread®

Viread® 300mg tablet qd

Group Type ACTIVE_COMPARATOR

Viread®

Intervention Type DRUG

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

Interventions

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DA-2802

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

Intervention Type DRUG

Viread®

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

Intervention Type DRUG

Other Intervention Names

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tenofovir disoproxil orotate tenofovir disoproxil fumarate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No