Back to resultsEfficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
Primary Purpose
Hepatitis B， Chronic
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-2802
Viread®
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B， Chronic
Eligibility Criteria
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:
- Total bilirubin levels greater than 2.5 mg/dl
- Prothrombin time is at least 3 seconds longer than normal upper limit
- Serum albumin value less than 30 g/l
- Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DA-2802
Viread®
Arm Description
DA-2802 319mg tablet qd
Viread® 300mg tablet qd
Outcomes
Primary Outcome Measures
Difference of HBV DNA level(log10)
Secondary Outcome Measures
Percentage of subjects HBV DNA < 400 copies/ml
Percentage of subjects who had normal ALT levels
Percentage of subjects who experienced loss of HBeAg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02967939
Brief Title
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B， Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-2802
Arm Type
Experimental
Arm Description
DA-2802 319mg tablet qd
Arm Title
Viread®
Arm Type
Active Comparator
Arm Description
Viread® 300mg tablet qd
Intervention Type
Drug
Intervention Name(s)
DA-2802
Other Intervention Name(s)
tenofovir disoproxil orotate
Intervention Description
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Intervention Type
Drug
Intervention Name(s)
Viread®
Other Intervention Name(s)
tenofovir disoproxil fumarate
Intervention Description
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
Primary Outcome Measure Information:
Title
Difference of HBV DNA level(log10)
Time Frame
Change from baseline at 48 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects HBV DNA < 400 copies/ml
Time Frame
at 24 weeks, 48 weeks
Title
Percentage of subjects who had normal ALT levels
Time Frame
at 24 week, 48 week
Title
Percentage of subjects who experienced loss of HBeAg
Time Frame
at 24 week, 48 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Total bilirubin levels greater than 2.5 mg/dl
Prothrombin time is at least 3 seconds longer than normal upper limit
Serum albumin value less than 30 g/l
Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong eun Yeon
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35315603
Citation
Kim HJ, Kim JH, Yeon JE, Seo YS, Jang JW, Cho YK, Jang BK, Han BH, Lee C, Lee JH, Yoon JH, Kim KM, Kim MY, Kim DY, Park NH, Cho EY, Lee JS, Lee JW, Kim IH, Song BC, Lee BS, Kwon OS. A Multi-Center, Double-Blind Randomized Controlled 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. J Korean Med Sci. 2022 Mar 21;37(11):e92. doi: 10.3346/jkms.2022.37.e92.
Results Reference
derived
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Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
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