Hepatitis B, ChronicPhase 4NCT02588937
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
A Phase 4 study testing EntecaBell ODT. 0.5mg and Baraclude Tab. 0.5mg in people with Hepatitis B, Chronic, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- EntecaBell ODT. 0.5mg and Baraclude Tab. 0.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Oct 2015to Jun 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 20 years old
- Patients with Chronic Hepatitis B diagnosed
- Patients who show positive HBsAg
- Patients who show positive HBeAg or negative HBeAg
- Patients who showed HBV DNA undetected(less than 300 copies/mL)
- Patients who have administered Baraclude Tab. 0.5mg for 1~4 years
- Patients who showed ALT less than 5 times of the upper limit in the normal range
- Patient who decided to participate and signed on an informed consent form willingly
Who cannot join
- Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- Patients with a uncompensated liver disease who have at least one of the following values or signs
- Total bilirubin > 2.5mg/dl
- Prothrombin time delayed more than three seconds of upper limit in the normal range
- Serum Albumin < 3 g/dL
- A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss
Show all 20Show fewer
- Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
- Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
- Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
- Administration of other Investigational Product within 30 days
- History of malignant tumor within 5 years (including leukemia and lymphoma)
- Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial
- Patients who have other hepatic diseases except hepatitis B
- Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks
- Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
- Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- Patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial
- Patients who received an organ transplant or are going to received an organ transplant
- Severe hypersensitivity to Entecavir
- Another clinical condition in investigator's judgement
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Dankook University Hospital
Cheonan, Chungcheongnam-do
Konkuk University Chungju Hospital
Chungju, North Chungcheong
Kyungpook National University Hospital
Daegu, Gyeong Sangbuk-do
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Chonnam National University Hospital
Gwangju, Jeollanam-do
Jeju National University Hospital
Jeju City, Jeju-do
Chonbuk National University Hospital
Jeonju, Jeollabuk-do
About this study
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
- Conditions
- Hepatitis B, Chronic
- Being tested
- EntecaBell ODT. 0.5mg, Baraclude Tab. 0.5mg
- Keywords
- Entecavir, EntecaBell ODT., Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecaBell ODT. 0.5mgDrug
Baraclude Tab. 0.5mgDrug
| Study group | Role | What they receive |
|---|---|---|
| EntecaBell ODT. | Experimental | Not described Receives: Drug: EntecaBell ODT. 0.5mg |
| Baraclude Tab. | Active comparator | Not described Receives: Drug: Baraclude Tab. 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Measured: 48 week
Secondary outcomes (7)
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Measured: 24 week
The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)
Measured: 24, 48 week
The rate of subjects who showed HBeAg serum loss
Measured: 24, 48 week
The rate of subjects who showed HBeAg seroconversion
Measured: 24, 48 week
The rate of subjects who showed HBsAg serum loss
Measured: 48 week
The rate of subjects who showed HBsAg seroconversion
Measured: 48 week
The rate of subjects who showed Virologic breakthrough
Measured: 12, 24, 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588937
- Sponsor's protocol ID
- 361HBV15017
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 14 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT02588937
- Acronym / sponsor ID
- 361HBV15017
- Conditions
- Hepatitis B, Chronic
- Keywords
- Entecavir, EntecaBell ODT., Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Oct 2015 (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.
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EntecaBell ODT. | Experimental | Drug: EntecaBell ODT. 0.5mg |
| Baraclude Tab. | Active comparator | Drug: Baraclude Tab. 0.5mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over the age of 20 years old
- Patients with Chronic Hepatitis B diagnosed
- Patients who show positive HBsAg
- Patients who show positive HBeAg or negative HBeAg
- Patients who showed HBV DNA undetected(less than 300 copies/mL)
Key exclusion criteria (20 listed)
- Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- Patients with a uncompensated liver disease who have at least one of the following values or signs
- Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
- Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
- Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
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 |
|---|---|---|
| EntecaBell ODT. 0.5mg | Drug | EntecaBell ODT. |
| Baraclude Tab. 0.5mg | Drug | Baraclude Tab. |
Primary outcome
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Time frame: 48 week
7 secondary outcomes
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Time frame: 24 week
The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)
Time frame: 24, 48 week
The rate of subjects who showed HBeAg serum loss
Time frame: 24, 48 week
The rate of subjects who showed HBeAg seroconversion
Time frame: 24, 48 week
The rate of subjects who showed HBsAg serum loss
Time frame: 48 week
The rate of subjects who showed HBsAg seroconversion
Time frame: 48 week
The rate of subjects who showed Virologic breakthrough
Time frame: 12, 24, 48 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EntecaBell ODT. 0.5mg and Baraclude Tab. 0.5mg in people with Hepatitis B, Chronic, run by Chong Kun Dang Pharmaceutical at 9 sites 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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
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 rate of subjects who showed HBV DNA undetected (less than 300copies/mL) (time frame: 48 week). 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 14 Dec 2016.