HBeAg-Positive Chronic Hepatitis BPhase 4NCT01913431
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
A Phase 4 study testing Baracle Tab.® and Baraclude Tab.® in people with HBeAg-Positive Chronic Hepatitis B, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBeAg-Positive Chronic Hepatitis B
- What is being tested?
- Baracle Tab.® and Baraclude Tab.®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2013to 6 Nov 2015
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
- Subjects with HBsAg-Positive diagnosed at the screening visit
- Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
- For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10^5 copies/ml
- For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10^5 copies/ml
- Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon
Who cannot join
- Subjects with HCV, HDV or HIV
- Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
- With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
- Less than 50ml/min of creatinine clearance diagnosed at the screening visit
- More than 50 ng/ml of alpha-fetoprotein at the screening visit
- Involved in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.
- Conditions
- HBeAg-Positive Chronic Hepatitis B
- Being tested
- Baracle Tab.®, Baraclude Tab.®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baracle Tab.®Drug
Baraclude Tab.®Drug
| Study group | Role | What they receive |
|---|---|---|
| Baracle Tab.® | Experimental | (It can be also placebo) dosage: 2 tablets daily for 48 weeks Receives: Drug: Baracle Tab.® |
| Baraclude Tab.® | Experimental | (It can be also placebo) dosage: 2 tablets daily for 48 weeks Receives: Drug: Baraclude Tab.® |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
measured at 24th week of the administration
Measured: 52 weeks
Secondary outcomes (3)
the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)
measured at 24th/48th week of the administration
Measured: 52 weeks
the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)
measured at 24th/48th week of the administration
Measured: 52 weeks
the percentage of participants who have lost HBeAg
HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study start12 Sep 2013
- Primary completion6 Nov 2015
- Study completion6 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBeAg-Positive Chronic Hepatitis BStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Chu Lee, M.D., Principal investigator, Asan Medical CenterSi Hyun Bae, M.D, Principal investigator, The Catholic University of KoreaJu Hyun Kim, M.D., Principal investigator, Gachon University of Medicine and Science Gil Medical CenterJae Seok Hwang, M.D., Principal investigator, Keimyung University Dongsan Medical CenterSo Young Kwon, M.D., Principal investigator, Konkuk University HospitalWon Young Tak, Principal investigator, Kyunpook National University HospitalJong Eun Yeon, M.D., Principal investigator, Korae University Guro HospitalSang Young Han, M.D., Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913431
- Sponsor's protocol ID
- ETV_HB_IV
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2013
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01913431
- Acronym / sponsor ID
- ETV_HB_IV
- Conditions
- HBeAg-Positive Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2013 (actual)
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 6 Nov 2015 (actual)
- First posted
- 1 Aug 2013 (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.
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baracle Tab.® | Experimental | Drug: Baracle Tab.®(It can be also placebo) dosage: 2 tablets daily for 48 weeks |
| Baraclude Tab.® | Experimental | Drug: Baraclude Tab.®(It can be also placebo) dosage: 2 tablets daily for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
- Subjects with HBsAg-Positive diagnosed at the screening visit
- Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
- For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10^5 copies/ml
- For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10^5 copies/ml
Key exclusion criteria (6 listed)
- Subjects with HCV, HDV or HIV
- Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
- With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
- Less than 50ml/min of creatinine clearance diagnosed at the screening visit
- More than 50 ng/ml of alpha-fetoprotein at the screening visit
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 |
|---|---|---|
| Baracle Tab.® | Drug | Baracle Tab.® |
| Baraclude Tab.® | Drug | Baraclude Tab.® |
Primary outcome
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
Time frame: 52 weeks
measured at 24th week of the administration
3 secondary outcomes
the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)
Time frame: 52 weeks
the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)
Time frame: 52 weeks
the percentage of participants who have lost HBeAg
Time frame: 52 weeks
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 31 Aug 2017.
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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.
Han Chu Lee, M.D. principal investigator
Asan Medical Center
Si Hyun Bae, M.D principal investigator
The Catholic University of Korea
Ju Hyun Kim, M.D. principal investigator
Gachon University of Medicine and Science Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baracle Tab.® and Baraclude Tab.® in people with HBeAg-Positive Chronic Hepatitis B, 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 6 inclusion and 6 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 31 Aug 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2017.