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

April 13, 2021 updated by: Dong-A ST Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-2802
DA-2802 319mg tablet qd
Drug: DA-2802
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Other Names:
  • tenofovir disoproxil orotate
Active Comparator: Viread®
Viread® 300mg tablet qd
Drug: Viread®
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
Other Names:
  • tenofovir disoproxil fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of HBV DNA level(log10)
Time Frame: Change from baseline at 48 weeks
Change from baseline at 48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Jong eun Yeon, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

January 23, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA2802_HB_III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B， Chronic

Clinical Trials on DA-2802

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe