Hepatitis B， ChronicPhase 3NCT02967939
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
A Phase 3 study testing DA-2802 and Viread® in people with Hepatitis B， Chronic, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B， Chronic
- What is being tested?
- DA-2802 and Viread®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2017to 15 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
Read the 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.
- Conditions
- Hepatitis B， Chronic
- Being tested
- DA-2802, Viread®
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-2802Drug
Also called tenofovir disoproxil orotate
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Viread®Drug
Also called tenofovir disoproxil fumarate
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
| Study group | Role | What they receive |
|---|---|---|
| DA-2802 | Experimental | DA-2802 319mg tablet qd Receives: Drug: DA-2802 |
| Viread® | Active comparator | Viread® 300mg tablet qd Receives: Drug: Viread® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of HBV DNA level(log10)
Measured: Change from baseline at 48 weeks
Secondary outcomes (3)
Percentage of subjects HBV DNA < 400 copies/ml
Measured: at 24 weeks, 48 weeks
Percentage of subjects who had normal ALT levels
Measured: at 24 week, 48 week
Percentage of subjects who experienced loss of HBeAg
Measured: at 24 week, 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start28 Mar 2017
- Primary completion23 Jan 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B， ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong eun Yeon, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967939
- Sponsor's protocol ID
- DA2802_HB_III
- Status last verified
- Apr 2021
- First submitted
- 14 Nov 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35315603
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02967939
- Acronym / sponsor ID
- DA2802_HB_III
- Conditions
- Hepatitis B， Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-2802 | Experimental | Drug: DA-2802DA-2802 319mg tablet qd |
| Viread® | Active comparator | Drug: Viread®Viread® 300mg tablet qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-2802Also: tenofovir disoproxil orotateDA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg. | Drug | DA-2802 |
| Viread®Also: tenofovir disoproxil fumarateViread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg. | Drug | Viread® |
Primary outcome
Difference of HBV DNA level(log10)
Time frame: Change from baseline at 48 weeks
3 secondary outcomes
Percentage of subjects HBV DNA < 400 copies/ml
Time frame: at 24 weeks, 48 weeks
Percentage of subjects who had normal ALT levels
Time frame: at 24 week, 48 week
Percentage of subjects who experienced loss of HBeAg
Time frame: at 24 week, 48 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 35315603Kim 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.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong eun Yeon principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-2802 and Viread® in people with Hepatitis B， Chronic, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of HBV DNA level(log10) (time frame: Change from baseline at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.