Clinical trial NCT02588937: Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Entecavir, EntecaBell ODT., Hepatitis B
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.


Eligibility criteria: Inclusion Criteria:

1. Over the age of 20 years old
2. Patients with Chronic Hepatitis B diagnosed
3. Patients who show positive HBsAg
4. Patients who show positive HBeAg or negative HBeAg
5. Patients who showed HBV DNA undetected(less than 300 copies/mL)
6. Patients who have administered Baraclude Tab. 0.5mg for 1\~4 years
7. Patients who showed ALT less than 5 times of the upper limit in the normal range
8. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

1. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
2. 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
3. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
4. Patients who showed Creatinine Clearance \< 50 mL/min by calculating Cockcroft-Gault equation
5. Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
6. Administration of other Investigational Product within 30 days
7. History of malignant tumor within 5 years (including leukemia and lymphoma)
8. 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
9. Patients who have other hepatic diseases except hepatitis B
10. Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks
11. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
12. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
13. 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
14. Patients who received an organ transplant or are going to received an organ transplant
15. Severe hypersensitivity to Entecavir
16. Another clinical condition in investigator's judgement

Primary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
timeFrame: 48 week
Secondary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
timeFrame: 24 week
measure: The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)
timeFrame: 24, 48 week
measure: The rate of subjects who showed HBeAg serum loss
timeFrame: 24, 48 week
measure: The rate of subjects who showed HBeAg seroconversion
timeFrame: 24, 48 week
measure: The rate of subjects who showed HBsAg serum loss
timeFrame: 48 week
measure: The rate of subjects who showed HBsAg seroconversion
timeFrame: 48 week
measure: The rate of subjects who showed Virologic breakthrough
timeFrame: 12, 24, 48 week
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Konkuk University Chungju Hospital
state: Chungcheongbuk-do
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: ChungCheongnam-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungcheongnam-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyeong sangbuk-do
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Gyeongsangbuk-do
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju-do
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jeollanam-do
Study officials:
References: