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Trial record 157 of 517 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02588937
First received: October 27, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: EntecaBell ODT. 0.5mg
Drug: Baraclude Tab. 0.5mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) [ Time Frame: 48 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) [ Time Frame: 24 week ] [ Designated as safety issue: No ]
  • The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10) [ Time Frame: 24, 48 week ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBeAg serum loss [ Time Frame: 24, 48 week ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBeAg seroconversion [ Time Frame: 24, 48 week ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBsAg serum loss [ Time Frame: 48 week ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBsAg seroconversion [ Time Frame: 48 week ] [ Designated as safety issue: No ]
  • The rate of subjects who showed Virologic breakthrough [ Time Frame: 12, 24, 48 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: October 2015
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EntecaBell ODT. Drug: EntecaBell ODT. 0.5mg
Active Comparator: Baraclude Tab. Drug: Baraclude Tab. 0.5mg

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02588937

Locations
Korea, Republic of
Konkuk University Chungju Hospital Recruiting
Chungju, Chungcheongbuk-do, Korea, Republic of
Contact: Jaedong Lee, MD    +82-43-840-8422    jdongl@kku.ac.kr   
Dankook University Hospital Not yet recruiting
Cheonan, ChungCheongnam-do, Korea, Republic of
Contact: Seokbae Kim, MD    +82-41-550-7114    dryakson@hanmail.net   
Chungnam National University Hospital Recruiting
Daejeon, Chungcheongnam-do, Korea, Republic of
Contact: Byungseok Lee, MD    +82-42-280-7125    gie001@cnuh.co.kr   
Kyungpook National University Hospital Recruiting
Daegu, Gyeong sangbuk-do, Korea, Republic of
Contact: Sooyoung Park, MD    +82-53-420-5519    psyoung0419@gmail.com   
Hanyang University Guri Hospital Not yet recruiting
Guri, Gyeonggi-do, Korea, Republic of
Contact: Joohyun Sohn, MD    +82-31-560-2189    sonjh@hanyang.ac.kr   
Yeungnam University Hospital Recruiting
Daegu, Gyeongsangbuk-do, Korea, Republic of
Contact: Heonju Lee, MD    +82-53-620-3834    hjlee@med.yu.ac.kr   
Jeju National University Hospital Recruiting
Jeju, Jeju-do, Korea, Republic of
Contact: Yukyung Cho, MD    +82-64-717-1165    choyk1120@hanmail.net   
Chonbuk National University Hospital Not yet recruiting
Jeonju, Jeollabuk-do, Korea, Republic of
Contact: Inhee Kim, MD    +82-63-250-1677    ihkimmd@jbnu.ac.kr   
Chonnam National University Hospital Recruiting
Gwangju, Jeollanam-do, Korea, Republic of
Contact: Sungkyu Choi, MD    +82-62-220-6203    choisk@chonnam.ac.kr   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02588937     History of Changes
Other Study ID Numbers: 361HBV15017 
Study First Received: October 27, 2015
Last Updated: October 27, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
Entecavir, EntecaBell ODT., Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016