Clinical trial NCT02523547: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: entecavir
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-08-14
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of patients with maintenance of HBV DNA undetectability
timeFrame: 48weeks
Secondary outcomes:
measure: The proportion of patients with HBeAg seroconversion
timeFrame: at week 12, 24, 36 and 48 of treatment
measure: The proportion of patients with HBeAg seroclearance
timeFrame: at week 12, 24, 36 and 48 of treatment
measure: The proportion with HBsAg seroclearance
timeFrame: at week 48 of treatment
measure: The proportion with HBeAg seroconversion and HBsAb positive
timeFrame: at week 48 of treatment
measure: Changes in serum HBV DNA levels
timeFrame: at week 48 of treatment
measure: Changes in HBsAg titer
timeFrame: at week 48 of treatment
measure: Changes in ALanine amino Transferase (ALT)
timeFrame: at week 48 of treatment
measure: Proportion of patients with virologic breakthrough
timeFrame: at week 48 of treatment
measure: Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
timeFrame: at week 48 of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 15 Sites
Study officials:
References: