NCT02588937

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 14, 2016

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

October 27, 2015

Last Update Submit

December 12, 2016

Conditions

Hepatitis B, Chronic

Keywords

Entecavir, EntecaBell ODT., Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)

    48 week

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

EntecaBell ODT.

EXPERIMENTAL
Drug: EntecaBell ODT. 0.5mg

Baraclude Tab.

ACTIVE COMPARATOR
Drug: Baraclude Tab. 0.5mg

Interventions

EntecaBell ODT. 0.5mgDRUG
EntecaBell ODT.
Baraclude Tab. 0.5mgDRUG
Baraclude Tab.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dankook University Hospital

Cheonan, Chungcheongnam-do, South Korea

Location

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Location

Kyungpook National University Hospital

Daegu, Gyeong Sangbuk-do, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Location

Yeungnam University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Location

Jeju National University Hospital

Jeju City, Jeju-do, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Chonnam National University Hospital

Gwangju, Jeollanam-do, South Korea

Location

Konkuk University Chungju Hospital

Chungju, North Chungcheong, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

December 14, 2016

Record last verified: 2015-10

Locations

KR(9)