Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: EntecaBell ODT. 0.5mg; Drug: Baraclude Tab. 0.5mg

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • ChungCheongnam-do
    • Cheonan, ChungCheongnam-do, Korea, Republic of
      • Dankook University Hospital
  • Chungcheongbuk-do
    • Chungju, Chungcheongbuk-do, Korea, Republic of
      • Konkuk University Chungju hospital
  • Chungcheongnam-do
    • Daejeon, Chungcheongnam-do, Korea, Republic of
      • Chungnam National University Hospital
  • Gyeong sangbuk-do
    • Daegu, Gyeong sangbuk-do, Korea, Republic of
      • Kyungpook National University Hospital
  • Gyeonggi-do
    • Guri, Gyeonggi-do, Korea, Republic of
      • Hanyang University Guri Hospital
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of
      • Yeungnam University Hospital
  • Jeju-do
    • Jeju, Jeju-do, Korea, Republic of
      • Jeju National University Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of
      • Chonbuk National University Hospital
  • Jeollanam-do
    • Gwangju, Jeollanam-do, Korea, Republic of
      • Chonnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EntecaBell ODT.	Drug: EntecaBell ODT. 0.5mg
Active Comparator: Baraclude Tab.	Drug: Baraclude Tab. 0.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)	48 week

Secondary Outcome Measures

Outcome Measure	Time Frame
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)	24 week
The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)	24, 48 week
The rate of subjects who showed HBeAg serum loss	24, 48 week
The rate of subjects who showed HBeAg seroconversion	24, 48 week
The rate of subjects who showed HBsAg serum loss	48 week
The rate of subjects who showed HBsAg seroconversion	48 week
The rate of subjects who showed Virologic breakthrough	12, 24, 48 week

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Entecavir, EntecaBell ODT., Hepatitis B
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: 361HBV15017