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

Hepatitis B, Chronic Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02588937
• Other study ID #: 361HBV15017
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 27, 2015
• Last updated: December 12, 2016
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• EntecaBell ODT. 0.5mg

• Baraclude Tab. 0.5mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)		48 week	No
Secondary	The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)		24 week	No
Secondary	The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)		24, 48 week	No
Secondary	The rate of subjects who showed HBeAg serum loss		24, 48 week	No
Secondary	The rate of subjects who showed HBeAg seroconversion		24, 48 week	No
Secondary	The rate of subjects who showed HBsAg serum loss		48 week	No
Secondary	The rate of subjects who showed HBsAg seroconversion		48 week	No
Secondary	The rate of subjects who showed Virologic breakthrough		12, 24, 48 week	No