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

August 13, 2015 updated by: Hanmi Pharmaceutical Company Limited

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

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cavir
entecavir/0.5mg/day
Drug: Cavir
0.5mg/day
Other Names:
  • entecavir
Active Comparator: Baraclude
entecavir/0.5mg/day
Drug: Baraclude
0.5mg/day
Other Names:
  • entecavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with maintenance of HBV DNA undetectability
Time Frame: 48weeks
analysis
48weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with HBeAg seroconversion
Time Frame: at week 12, 24, 36 and 48 of treatment
analysis
at week 12, 24, 36 and 48 of treatment
The proportion of patients with HBeAg seroclearance
Time Frame: at week 12, 24, 36 and 48 of treatment
analysis
at week 12, 24, 36 and 48 of treatment
The proportion with HBsAg seroclearance
Time Frame: at week 48 of treatment
analysis
at week 48 of treatment
The proportion with HBeAg seroconversion and HBsAb positive
Time Frame: at week 48 of treatment
analysis
at week 48 of treatment
Changes in serum HBV DNA levels
Time Frame: at week 48 of treatment
analysis
at week 48 of treatment
Changes in HBsAg titer
Time Frame: at week 48 of treatment
analysis
at week 48 of treatment
Changes in ALanine amino Transferase (ALT)
Time Frame: at week 48 of treatment
analysis
at week 48 of treatment
Proportion of patients with virologic breakthrough
Time Frame: at week 48 of treatment
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
at week 48 of treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
Time Frame: at week 48 of treatment
questionnaire
at week 48 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

July 26, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-CAV-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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