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Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cavir
Baraclude
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring entecavir

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.

Exclusion Criteria:

  • Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
  • Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
  • Patient had documented resistance mutations at any time before or at screening
  • Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
  • Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
  • Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
  • Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3
  • Patient is pregnant or breastfeeding or willing to be pregnant
  • Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years

Sites / Locations

  • 15 SitesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cavir

Baraclude

Arm Description

entecavir/0.5mg/day

entecavir/0.5mg/day

Outcomes

Primary Outcome Measures

The proportion of patients with maintenance of HBV DNA undetectability
analysis

Secondary Outcome Measures

The proportion of patients with HBeAg seroconversion
analysis
The proportion of patients with HBeAg seroclearance
analysis
The proportion with HBsAg seroclearance
analysis
The proportion with HBeAg seroconversion and HBsAb positive
analysis
Changes in serum HBV DNA levels
analysis
Changes in HBsAg titer
analysis
Changes in ALanine amino Transferase (ALT)
analysis
Proportion of patients with virologic breakthrough
virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
questionnaire

Full Information

First Posted
July 26, 2015
Last Updated
August 13, 2015
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02523547
Brief Title
Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude
Official Title
PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
Detailed Description
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
entecavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cavir
Arm Type
Experimental
Arm Description
entecavir/0.5mg/day
Arm Title
Baraclude
Arm Type
Active Comparator
Arm Description
entecavir/0.5mg/day
Intervention Type
Drug
Intervention Name(s)
Cavir
Other Intervention Name(s)
entecavir
Intervention Description
0.5mg/day
Intervention Type
Drug
Intervention Name(s)
Baraclude
Other Intervention Name(s)
entecavir
Intervention Description
0.5mg/day
Primary Outcome Measure Information:
Title
The proportion of patients with maintenance of HBV DNA undetectability
Description
analysis
Time Frame
48weeks
Secondary Outcome Measure Information:
Title
The proportion of patients with HBeAg seroconversion
Description
analysis
Time Frame
at week 12, 24, 36 and 48 of treatment
Title
The proportion of patients with HBeAg seroclearance
Description
analysis
Time Frame
at week 12, 24, 36 and 48 of treatment
Title
The proportion with HBsAg seroclearance
Description
analysis
Time Frame
at week 48 of treatment
Title
The proportion with HBeAg seroconversion and HBsAb positive
Description
analysis
Time Frame
at week 48 of treatment
Title
Changes in serum HBV DNA levels
Description
analysis
Time Frame
at week 48 of treatment
Title
Changes in HBsAg titer
Description
analysis
Time Frame
at week 48 of treatment
Title
Changes in ALanine amino Transferase (ALT)
Description
analysis
Time Frame
at week 48 of treatment
Title
Proportion of patients with virologic breakthrough
Description
virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment
Time Frame
at week 48 of treatment
Title
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
Description
questionnaire
Time Frame
at week 48 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening. Exclusion Criteria: Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC) Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV) Patient had documented resistance mutations at any time before or at screening Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease. Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study. Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks. Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3 Patient is pregnant or breastfeeding or willing to be pregnant Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanmi Pharmaceutical
First Name & Middle Initial & Last Name or Official Title & Degree
EunSol Kim
Phone
+82-2-410-8747
Email
snow-white@hanmi.co.kr
Facility Information:
Facility Name
15 Sites
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MoonHwa Park, MD
Phone
8224109190
Email
moonwha.park@hanmi.co.kr

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

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