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

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Baraclude; Drug: Cavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02523547

HM-CAV-401

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Cavir

Experimental group

Description:

entecavir/0.5mg/day

Treatment:

Drug: Cavir

Baraclude

Active Comparator group

Description:

entecavir/0.5mg/day

Treatment:

Drug: Baraclude